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AUVELITY dextromethorphan hydrobromide, bupropion hydrochloride 45 mg; 105 mg Tablet, Multilayer, Extended Release, 14-count — NDC 81968-0045-14 package photo

AUVELITY dextromethorphan hydrobromide, bupropion hydrochloride 45 mg; 105 mg Tablet, Multilayer, Extended Release, 14-count

by Axsome Therapeutics, Inc. · 1 BOTTLE in 1 CARTON (81968-045-14) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
NDC 81968-0045-14
🏷️ FDA NDC (as labeled) 81968-045-14 billing pads the product segment with a zero
This package
Contains14-count Pack sizes4 compare ↓
Also priced by: Part D plans $20.01/unit — full pricing hub ↓
Also comes in: 30 tablets 81968-0045-30 30 tablets 81968-0045-31 60 tablets 81968-0045-60
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 81968-045-14
Product NDC 81968-045
11-digit billing NDC 81968004514
RxCUI 2611260, 2611266, 2741701, 2741703, 2744512, 2744513, 2744514, 2744515
UNII ZG7E5POY8O, 9D2RTI9KYH
UPC 0381968045600, 0381968030224, 0381968045310, 0381968045143
Application # NDA215430
SPL Set ID dcefda7c-9a68-278e-e053-2995a90aec79
Established class (EPC) Aminoketone; Sigma-1 Agonist; Uncompetitive N-methyl-D-asparta
Mechanism of action Dopamine Uptake Inhibitors; Norepinephrine Uptake Inhibitors; Sigma-1 Receptor Agonists
Physiologic effect Increased Dopamine Activity; Increased Norepinephrine Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-08-18
Route ORAL
Dosage form TABLET, MULTILAYER, EXTENDED RELEASE
Substance DEXTROMETHORPHAN HYDROBROMIDE; BUPROPION HYDROCHLORIDE
GCN Seq No 083732
GCN 52775
HICL code 048220
Ingredient (HICL) Dextromethorphan Hbr/Bupropion
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H8
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 2)
HIC3 code H81
Therapeutic class — specific (HIC3) Ndma Receptor Antagonist And Ndri Comb
AHFS code 28:16.04.92
AHFS class Antidepressants, Miscellaneous
FDB label name AUVELITY ER 45-105 MG TABLET
FDB brand name Auvelity
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 81968-045-14 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 81968-0045-14. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist
Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives
How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAxsome Therapeutics, Inc.
Application holderAXSOME THERAPEUTICS INC
FDA applicationNDA215430 (NDA)
Labeler code81968
First marketedAug 2022
Product typeHuman Prescription Drug
Portfolio7 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name AUVELITY ER 45-105 MG TABLET Ingredient Dextromethorphan Hbr/Bupropion
📗 Our plain-language guide HelloPharmacist
  • Auvelity is a prescription tablet that combines two ingredients — dextromethorphan and bupropion — in one pill. Your doctor might prescribe it if you have major depressive disorder...
  • What exactly is Auvelity and why might my doctor prescribe it?
  • You can take Auvelity with or without food, so that part is flexible. The key rules are: swallow the tablet whole (don't crush, chew, or split it), and if you're on a twice-daily s...
  • How do I take Auvelity — does it matter when I take it or whether I eat first?
📖 Read our full Dextromethorphan and Bupropion guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Brown / white
ShapeRound
Imprint45;105
Size11 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII ZT934N0X4W
    A naturally occurring amino acid salt used as a reducing agent and antioxidant in medications. It helps prevent ingredient breakdown and may improve product stability during storage.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

14 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $20.01 $280.07 / 14 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Auvelity 45 mg/1; 105 mgthis 81968-0045-14 Axsome 14 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2022
First FDA approval
Aug 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2043
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2043. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 18, 2022 RLD RS ⏳ ~17.2 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 12146889 — method of use (U-3419)
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US 9408815 — method of use (U-4517)
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US 10463634 — method of use (U-4517)
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Exclusivity I-913
Exclusivity I-913
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LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (268)
PatentTypeUse codeExpires
US 12146889 ↗ Method of use U-3419 Feb 23, 2043
US 11524008 ↗ Method of use U-3419 Nov 5, 2034
US 11524007 ↗ Method of use U-3419 Nov 5, 2034
US 11517542 ↗ Method of use U-3419 Nov 5, 2034
US 11517543 ↗ Method of use U-3419 Nov 5, 2034
US 11510918 ↗ Method of use U-3419 Nov 5, 2034
US 12310961 ↗ Method of use U-3419 Jan 20, 2043
US 11382874 ↗ Method of use U-3419 Nov 5, 2034
US 11364233 ↗ Method of use U-3419 Nov 5, 2034
US 9457025 ↗ Method of use U-3419 Nov 5, 2034
US 10058518 ↗ Method of use U-3419 Nov 5, 2034
US 9278095 ↗ Method of use U-3419 Nov 5, 2034
US 9867819 ↗ Method of use U-3419 Nov 5, 2034
US 9168234 ↗ Method of use U-3419 Nov 5, 2034
US 9861595 ↗ Method of use U-3419 Nov 5, 2034
US 8569328 ↗ Method of use U-3419 Jul 18, 2032
US 9700553 ↗ Method of use U-3419 Nov 5, 2034
US 11357744 ↗ Method of use U-3419 Nov 5, 2034
US 11344544 ↗ Method of use U-3419 Nov 5, 2034
US 9486450 ↗ Method of use U-3419 Nov 5, 2034
US 9474731 ↗ Method of use U-3419 Nov 5, 2034
US 9375429 ↗ Method of use U-3419 Nov 5, 2034
US 9421176 ↗ Method of use U-3419 Nov 5, 2034
US 9408815 ↗ Method of use U-3419 Nov 5, 2034
US 9763932 ↗ Method of use U-3419 Nov 5, 2034
US 11311534 ↗ Method of use U-3419 Nov 5, 2034
US 9205083 ↗ Method of use U-3419 Nov 5, 2034
US 9707191 ↗ Method of use U-3419 Nov 5, 2034
US 10898453 ↗ Method of use U-3419 Nov 5, 2034
US 11433067 ↗ Method of use U-3419 Nov 5, 2034
US 9700528 ↗ Method of use U-3419 Nov 5, 2034
US 9370513 ↗ Method of use U-3419 Nov 5, 2034
US 9457023 ↗ Method of use U-3419 Nov 5, 2034
US 9238032 ↗ Method of use U-3419 Nov 5, 2034
US 11096937 ↗ Method of use U-3419 Nov 5, 2034
US 11298352 ↗ Method of use U-3419 Nov 5, 2034
US 10966941 ↗ Method of use U-3419 Nov 5, 2034
US 11298351 ↗ Method of use U-3419 Nov 5, 2034
US 11090300 ↗ Method of use U-3419 Nov 5, 2034
US 10894047 ↗ Method of use U-3419 Nov 5, 2034
US 10064857 ↗ Method of use U-3419 Nov 5, 2034
US 11291665 ↗ Method of use U-3419 Nov 5, 2034
US 10780066 ↗ Method of use U-3419 Nov 5, 2034
US 10780064 ↗ Method of use U-3419 Jan 7, 2040
US 11291638 ↗ Method of use U-3419 Nov 5, 2034
US 10786469 ↗ Method of use U-3419 Nov 5, 2034
US 11253492 ↗ Method of use U-3419 Nov 5, 2034
US 10881657 ↗ Method of use U-3419 Nov 5, 2034
US 10874663 ↗ Method of use U-3419 Nov 5, 2034
US 10799497 ↗ Method of use U-3419 Nov 5, 2034
US 11058648 ↗ Method of use U-3419 Nov 5, 2034
US 11273133 ↗ Method of use U-3419 Nov 5, 2034
US 10864209 ↗ Method of use U-3419 Nov 5, 2034
US 10806710 ↗ Method of use U-3419 Nov 5, 2034
US 10881624 ↗ Method of use U-3419 Nov 5, 2034
US 10786496 ↗ Method of use U-3419 Nov 5, 2034
US 11020389 ↗ Method of use U-3419 Nov 5, 2034
US 11185515 ↗ Method of use U-3419 Nov 5, 2034
US 10945973 ↗ Method of use U-3419 Nov 5, 2034
US 10966942 ↗ Method of use U-3419 Jan 7, 2040
US 11285146 ↗ Method of use U-3419 Nov 5, 2034
US 11285118 ↗ Method of use U-3419 Nov 5, 2034
US 10596167 ↗ Method of use U-3419 Nov 5, 2034
US 11439636 ↗ Method of use U-3419 Nov 5, 2034
US 9314462 ↗ Method of use U-3419 Nov 5, 2034
US 9198905 ↗ Method of use U-3419 Nov 5, 2034
US 11426401 ↗ Method of use U-3419 Nov 5, 2034
US 11426370 ↗ Method of use U-3419 Nov 5, 2034
US 11419867 ↗ Method of use U-3419 Nov 5, 2034
US 12390428 ↗ Method of use U-3419 Dec 1, 2041
US 10772850 ↗ Method of use U-3419 Nov 5, 2034
US 10940124 ↗ Method of use U-3419 Jan 7, 2040
US 11273134 ↗ Method of use U-3419 Nov 5, 2034
US 11253491 ↗ Method of use U-3419 Nov 5, 2034
US 11234946 ↗ Method of use U-3419 Nov 5, 2034
US 10548857 ↗ Method of use U-3419 Nov 5, 2034
US 11229640 ↗ Method of use U-3419 Nov 5, 2034
US 10874665 ↗ Method of use U-3419 Nov 5, 2034
US 10933034 ↗ Method of use U-3419 Nov 5, 2034
US 10251879 ↗ Method of use U-3419 Nov 5, 2034
US 10925842 ↗ Method of use U-3419 Jan 7, 2040
US 10092561 ↗ Method of use U-3419 Nov 5, 2034
US 10894046 ↗ Method of use U-3419 Nov 5, 2034
US 11191739 ↗ Method of use U-3419 Nov 5, 2034
US 10874664 ↗ Method of use U-3419 Nov 5, 2034
US 10080727 ↗ Method of use U-3419 Nov 5, 2034
US 11197839 ↗ Method of use U-3419 Nov 5, 2034
US 11147808 ↗ Method of use U-3419 Nov 5, 2034
US 11207281 ↗ Method of use U-3419 Nov 5, 2034
US 11141416 ↗ Method of use U-3419 Nov 5, 2034
US 11141388 ↗ Method of use U-3419 Nov 5, 2034
US 11213521 ↗ Method of use U-3419 Nov 5, 2034
US 11129826 ↗ Method of use U-3419 Nov 5, 2034
US 11123343 ↗ Method of use U-3419 Nov 5, 2034
US 10966974 ↗ Method of use U-3419 Nov 5, 2034
US 10512643 ↗ Method of use U-3419 Nov 5, 2034
US 10463634 ↗ Method of use U-3419 Nov 5, 2034
US 10105361 ↗ Method of use U-3419 Nov 5, 2034
US 10105327 ↗ Method of use U-3419 Nov 5, 2034
US 10092560 ↗ Method of use U-3419 Nov 5, 2034
US 11752144 ↗ Method of use U-3419 Feb 23, 2043
US 11925636 ↗ Method of use U-3419 Jan 20, 2043
US 9968568 ↗ Method of use U-3419 Nov 5, 2034
US 12042473 ↗ Method of use U-3419 Feb 23, 2043
US 12036191 ↗ Method of use U-3419 Feb 15, 2043
US 11969421 ↗ Method of use U-3419 Nov 5, 2034
US 11590124 ↗ Method of use U-3419 Nov 5, 2034
US 11576909 ↗ Method of use U-3419 Nov 5, 2034
US 11571417 ↗ Method of use U-3419 Nov 5, 2034
US 11123344 ↗ Method of use U-3419 Nov 5, 2034
US 11065248 ↗ Method of use U-3419 Nov 5, 2034
US 11896563 ↗ Method of use U-3419 Dec 1, 2041
US 12357697 ↗ Method of use U-3419 Jan 20, 2043
US 11478468 ↗ Method of use U-3419 Nov 5, 2034
US 11541048 ↗ Method of use U-3419 Nov 5, 2034
US 11541021 ↗ Method of use U-3419 Nov 5, 2034
US 11534414 ↗ Method of use U-3419 Nov 5, 2034
US 11779579 ↗ Method of use U-3419 Nov 5, 2034
US 11617728 ↗ Method of use U-3419 Nov 5, 2034
US 11617747 ↗ Method of use U-3563 Nov 5, 2034
US 11730706 ↗ Method of use U-3419 Jan 23, 2043
US 11717518 ↗ Method of use U-3419 Jan 20, 2043
US 11596627 ↗ Method of use U-3419 Nov 5, 2034
US 11497721 ↗ Method of use U-3419 Nov 5, 2034
US 11844797 ↗ Method of use U-3778 Apr 20, 2043
US 11839612 ↗ Method of use U-3419 Mar 2, 2043
US 11883373 ↗ Method of use U-3419 Jan 23, 2043
US 11986444 ↗ Method of use U-3419 Feb 15, 2043
US 12109178 ↗ Method of use U-3419 Nov 5, 2034
US 12653795 ↗ Method of use U-4516 Nov 28, 2043
US 12661408 ↗ Method of use U-3419 Jan 20, 2043
US 9968568 ↗ Method of use U-4517 Nov 5, 2034
US 9968568 ↗ Method of use U-4517 Nov 5, 2034
US 11285146 ↗ Method of use U-4517 Nov 5, 2034
US 9168234 ↗ Method of use U-4517 Nov 5, 2034
US 9168234 ↗ Method of use U-4517 Nov 5, 2034
US 8569328 ↗ Method of use U-4516 Jul 18, 2032
US 10080727 ↗ Method of use U-4520 Nov 5, 2034
US 11382874 ↗ Method of use U-4517 Nov 5, 2034
US 11344544 ↗ Method of use U-4517 Nov 5, 2034
US 11571417 ↗ Method of use U-4526 Nov 5, 2034
US 11590124 ↗ Method of use U-4526 Nov 5, 2034
US 11298352 ↗ Method of use U-4517 Nov 5, 2034
US 11291638 ↗ Method of use U-4517 Nov 5, 2034
US 12370154 ↗ Method of use U-4518 Feb 15, 2043
US 12472155 ↗ Method of use U-4519 Feb 23, 2043
US 12194036 ↗ Method of use U-4521 Apr 20, 2043
US 12576078 ↗ Method of use U-4516 Jun 5, 2040
US 12576078 ↗ Method of use U-4516 Jun 5, 2040
US 12239642 ↗ Method of use U-4515 Jan 20, 2043
US 12194005 ↗ Method of use U-4523 Jan 23, 2043
US 12599576 ↗ Method of use U-4518 Feb 15, 2043
US 12364674 ↗ Method of use U-4516 Jan 23, 2043
US 11007189 ↗ Method of use U-4516 Nov 5, 2034
US 11007189 ↗ Method of use U-4516 Nov 5, 2034
US 12472174 ↗ Method of use U-4515 Jan 20, 2043
US 12472174 ↗ Method of use U-4515 Jan 20, 2043
US 12263161 ↗ Method of use U-4515 Jan 20, 2043
US 11534414 ↗ Method of use U-4516 Nov 5, 2034
US 11191739 ↗ Method of use U-4516 Nov 5, 2034
US 11197839 ↗ Method of use U-4516 Nov 5, 2034
US 11234946 ↗ Method of use U-4526 Nov 5, 2034
US 10881624 ↗ Method of use U-4517 Nov 5, 2034
US 9700528 ↗ Method of use U-4517 Nov 5, 2034
US 11253492 ↗ Method of use U-4526 Nov 5, 2034
US 9861595 ↗ Method of use U-4517 Nov 5, 2034
US 9861595 ↗ Method of use U-4517 Nov 5, 2034
US 9486450 ↗ Method of use U-4517 Nov 5, 2034
US 9314462 ↗ Method of use U-4517 Nov 5, 2034
US 9205083 ↗ Method of use U-4520 Nov 5, 2034
US 10092560 ↗ Method of use U-4517 Nov 5, 2034
US 11207281 ↗ Method of use U-4537 Nov 5, 2034
US 9457025 ↗ Method of use U-4517 Nov 5, 2034
US 9421176 ↗ Method of use U-4517 Nov 5, 2034
US 9700553 ↗ Method of use U-4517 Nov 5, 2034
US 9486450 ↗ Method of use U-4517 Nov 5, 2034
US 9370513 ↗ Method of use U-4520 Nov 5, 2034
US 9375429 ↗ Method of use U-4517 Nov 5, 2034
US 9314462 ↗ Method of use U-4517 Nov 5, 2034
US 9370513 ↗ Method of use U-4520 Nov 5, 2034
US 9457023 ↗ Method of use U-4517 Nov 5, 2034
US 9707191 ↗ Method of use U-4522 Nov 5, 2034
US 9474731 ↗ Method of use U-4520 Nov 5, 2034
US 11207281 ↗ Method of use U-4537 Nov 5, 2034
US 10092560 ↗ Method of use U-4517 Nov 5, 2034
US 11590124 ↗ Method of use U-4526 Nov 5, 2034
US 10780066 ↗ Method of use U-4517 Nov 5, 2034
US 9198905 ↗ Method of use U-4520 Nov 5, 2034
US 8569328 ↗ Method of use U-4516 Jul 18, 2032
US 9205083 ↗ Method of use U-4520 Nov 5, 2034
US 11253492 ↗ Method of use U-4526 Nov 5, 2034
US 9707191 ↗ Method of use U-4522 Nov 5, 2034
US 9198905 ↗ Method of use U-4520 Nov 5, 2034
US 10058518 ↗ Method of use U-4522 Nov 5, 2034
US 10064857 ↗ Method of use U-4517 Nov 5, 2034
US 11571417 ↗ Method of use U-4526 Nov 5, 2034
US 11426370 ↗ Method of use U-4526 Nov 5, 2034
US 10092561 ↗ Method of use U-4517 Nov 5, 2034
US 10105361 ↗ Method of use U-4522 Nov 5, 2034
US 10780066 ↗ Method of use U-4517 Nov 5, 2034
US 10251879 ↗ Method of use U-4517 Nov 5, 2034
US 10058518 ↗ Method of use U-4522 Nov 5, 2034
US 11285146 ↗ Method of use U-4517 Nov 5, 2034
US 11273134 ↗ Method of use U-4517 Nov 5, 2034
US 11273134 ↗ Method of use U-4517 Nov 5, 2034
US 11273133 ↗ Method of use U-4526 Nov 5, 2034
US 11273133 ↗ Method of use U-4526 Nov 5, 2034
US 11298352 ↗ Method of use U-4517 Nov 5, 2034
US 11344544 ↗ Method of use U-4517 Nov 5, 2034
US 11426370 ↗ Method of use U-4526 Nov 5, 2034
US 11382874 ↗ Method of use U-4517 Nov 5, 2034
US 12433884 ↗ Method of use U-4514 Jun 5, 2040
US 12433884 ↗ Method of use U-4514 Jun 5, 2040
US 12564587 ↗ Method of use U-4515 Jan 20, 2043
US 12478622 ↗ Method of use U-4515 Jan 20, 2043
US 12472156 ↗ Method of use U-4516 Jun 5, 2040
US 12472156 ↗ Method of use U-4516 Jun 5, 2040
US 11065248 ↗ Method of use U-4517 Nov 5, 2034
US 11433067 ↗ Method of use U-4516 Nov 5, 2034
US 11357744 ↗ Method of use U-4517 Nov 5, 2034
US 11576909 ↗ Method of use U-4526 Nov 5, 2034
US 11439636 ↗ Method of use U-4517 Nov 5, 2034
US 11426401 ↗ Method of use U-4517 Nov 5, 2034
US 10966941 ↗ Method of use U-4517 Nov 5, 2034
US 10806710 ↗ Method of use U-4517 Nov 5, 2034
US 10596167 ↗ Method of use U-4517 Nov 5, 2034
US 11234946 ↗ Method of use U-4526 Nov 5, 2034
US 9763932 ↗ Method of use U-4517 Nov 5, 2034
US 11617747 ↗ Method of use U-4526 Nov 5, 2034
US 11291638 ↗ Method of use U-4517 Nov 5, 2034
US 11285118 ↗ Method of use U-4526 Nov 5, 2034
US 11285118 ↗ Method of use U-4526 Nov 5, 2034
US 11419867 ↗ Method of use U-4517 Nov 5, 2034
US 11419867 ↗ Method of use U-4517 Nov 5, 2034
US 11291665 ↗ Method of use U-4517 Nov 5, 2034
US 11291665 ↗ Method of use U-4517 Nov 5, 2034
US 9278095 ↗ Method of use U-4517 Nov 5, 2034
US 9867819 ↗ Method of use U-4517 Nov 5, 2034
US 9763932 ↗ Method of use U-4517 Nov 5, 2034
US 9700553 ↗ Method of use U-4517 Nov 5, 2034
US 9700528 ↗ Method of use U-4517 Nov 5, 2034
US 9457023 ↗ Method of use U-4517 Nov 5, 2034
US 9421176 ↗ Method of use U-4517 Nov 5, 2034
US 9408815 ↗ Method of use U-4517 Nov 5, 2034
US 9238032 ↗ Method of use U-4520 Nov 5, 2034
US 9474731 ↗ Method of use U-4520 Nov 5, 2034
US 9457025 ↗ Method of use U-4517 Nov 5, 2034
US 9867819 ↗ Method of use U-4517 Nov 5, 2034
US 11123344 ↗ Method of use U-4517 Nov 5, 2034
US 10786496 ↗ Method of use U-4517 Nov 5, 2034
US 10105361 ↗ Method of use U-4522 Nov 5, 2034
US 10092561 ↗ Method of use U-4517 Nov 5, 2034
US 9278095 ↗ Method of use U-4517 Nov 5, 2034
US 9238032 ↗ Method of use U-4520 Nov 5, 2034
US 9375429 ↗ Method of use U-4517 Nov 5, 2034
US 10512643 ↗ Method of use U-4517 Nov 5, 2034
US 10512643 ↗ Method of use U-4517 Nov 5, 2034
US 10080727 ↗ Method of use U-4520 Nov 5, 2034
US 10251879 ↗ Method of use U-4517 Nov 5, 2034
US 9408815 ↗ Method of use U-4517 Nov 5, 2034
US 10463634 ↗ Method of use U-4517 Nov 5, 2034
US 10463634 ↗ Method of use U-4517 Nov 5, 2034
US 11617747 ↗ Method of use U-4526 Nov 5, 2034
US 10881624 ↗ Method of use U-4517 Nov 5, 2034
US 10064857 ↗ Method of use U-4517 Nov 5, 2034
US 12678506 ↗ Drug product — Jan 20, 2043
US 12678506 ↗ Drug product — Jan 20, 2043
US 12156914 ↗ Drug product — Jan 20, 2043
FDA exclusivity
CodeWhat it grantsExpires
I-913New indication (3-year)Apr 30, 2029
I-913New indication (3-year)Apr 30, 2029
Common questions
Is there a generic version of AUVELITY ER 45-105 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for AUVELITY ER 45-105 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Nov 2043 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
60 tablets81968-0045-60 98,020 Rx · $102,496,683
30 tablets81968-0045-30 36,130 Rx · $35,079,778
14 tablets this page81968-0045-14 No Medicaid data
30 tablets81968-0045-31 No Medicaid data
Drug total (last 4 qtrs): 134,150 Rx · 7,320,988 units · $137,576,462 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Auvelity — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Auvelity. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$40.63M
Claims incl. refills
34.9K
Beneficiaries
16.5K
Spend / beneficiary
$2,456.99
Spend / claim
$1,164.38
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for AUVELITY (this brand).

Top reported reactions

Dizziness308
Feeling Abnormal273
Anxiety214
Nausea169
Fatigue162
Depression160
Headache144

Age at onset

Child2
Adolescent4
Adult1,248
Elderly266

Reporter sex

0 reports

Serious outcomes

Hospitalization179
Death33
Disabling15
Life-threatening8
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 1,091 543
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
81968-0045-30 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30) $19.90 / ea $596.88 2022-08-18 Active
81968-0045-14 You're viewing this 1 BOTTLE in 1 CARTON (81968-045-14) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE — — 2024-09-18 Active
81968-0045-31 1 BOTTLE in 1 CARTON (81968-045-31) / 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE — — 2024-05-10 Active
81968-0045-60 60 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-60) $19.90 / ea $1,193.75 2024-06-28 Active

This pack shows little to no recent Medicaid volume — the 60 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 81968-0045-14?
NDC 81968-0045-14 is a 14-count package — 1 bottle in 1 carton / 14 tablet, multilayer, extended release in 1 bottle.
What is the difference between NDC 81968-0045-14 and NDC 81968-0045-30?
Both are AUVELITY dextromethorphan hydrobromide, bupropion hydrochloride 45 mg; 105 mg Tablet, Multilayer, Extended Release — the drug itself is identical. NDC 81968-0045-14 is the 14-count package, while NDC 81968-0045-30 is the 30 tablets package.
What NDC number is used to bill for this package of AUVELITY dextromethorphan hydrobromide, bupropion hydrochloride 45 mg; 105 mg Tablet, Multilayer, Extended Release?
Bill NDC 81968-0045-14 — the 11-digit billing format is 81968004514. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 81968-045-14, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 81968-0045-14, written without dashes as 81968004514. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 81968-0045-14, the first segment (81968) is the labeler code FDA assigned to Axsome Therapeutics, Inc.; the middle segment (0045) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (14) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Axsome Therapeutics, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 30 tablets (81968-0045-30), 30 tablets (81968-0045-31), 60 tablets (81968-0045-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Axsome Therapeutics, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 117 words ▾

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)] . AUVELITY is not approved for use in pediatric patients [see Use in Specific Populations (8.4)] .

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors.

AUVELITY is not approved for use in pediatric patients. ( 5.1 , 8.4 )

🎯 Indications and Usage 151 words ▾

1 INDICATIONS AND USAGE AUVELITY is a combination of dextromethorphan, an uncompetitive N -methyl D -aspartate (NMDA) receptor antagonist and sigma-1 receptor agonist, and bupropion, an aminoketone and CYP450 2D6 inhibitor, indicated for the treatment of major depressive disorder (MDD) in adults ( 1.1 ) the treatment of agitation associated with dementia due to Alzheimer’s disease ( 1.2 ) Limitations of Use: AUVELITY is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease (1.2).

1.1Major Depressive Disorder AUVELITY is indicated for the treatment of major depressive disorder (MDD) in adults.

1.2Agitation Associated with Dementia Due to Alzheimer’s Disease AUVELITY is indicated for the treatment of agitation associated with dementia due to Alzheimer’s disease. Limitations of Use: AUVELITY is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease [see Clinical Studies Section 14.2 ].

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Prior to initiating treatment with AUVELITY: assess blood pressure; screen patients for history of bipolar disorder, mania, or hypomania; and determine if patients are receiving any other medications that contain bupropion or dextromethorphan. ( 2.1 ) For MDD, the starting dosage is AUVELITY 45 mg/105 mg once daily in the morning. On day 4, increase to the maximum recommended dosage of AUVELITY 45 mg/105 mg twice daily, separated by at least 8 hours.

Do not exceed two doses within the same day. ( 2.2 ) For agitation associated with dementia due to Alzheimer’s disease, the starting dosage is AUVELITY 30 mg/105 mg once daily in the morning. On day 8, increase to AUVELITY 30 mg/105 mg twice daily, separated by at least 8 hours, based on tolerability.

On day 15, increase to the maximum recommended dosage of AUVELITY 45 mg/105 mg twice daily, separated by at least 8 hours, based on tolerability. Do not exceed two doses within the same day. ( 2.3 ) Swallow tablets whole, do not crush, divide, or chew.

( 2.2 , 2.3 ) Moderate renal impairment: For patients with MDD or agitation associated with dementia due to Alzheimer’s disease, the maximum recommended dosage is one tablet of 45 mg/105 mg by mouth once daily in the morning. ( 2.4 , 8.6 ) CYP2D6 poor metabolizers: For patients with MDD or agitation associated with dementia due to Alzheimer’s disease, the maximum recommended dosage is one tablet of 45 mg/105 mg by mouth once daily in the morning. ( 2.6 , 8.8 , 12.3 )

2.1Important Recommendations Prior to Initiating and During Treatment with AUVELITY Prior to initiating and during treatment with AUVELITY: assess blood pressure and monitor periodically during treatment [see Warnings and Precautions ( 5.3 )] . screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.4 )] . screen patients to determine if they are receiving any other medications that contain bupropion or dextromethorphan [see Warnings and Precautions ( 5.2 , 5.5 , 5.8 )] .

2.2Recommended Dosage for the Treatment of Major Depressive Disorder The recommended starting dosage ofis AUVELITY (45 mg of dextromethorphan hydrobromide and /105 mg of bupropion hydrochloride) is one tablet once daily in the morning. After 3 daysOn day 4, increase to the maximum recommended dosage of one tablet twice daily, given at least 8 hours apart. Do not exceed two doses within the same day.

Administer AUVELITY orally with or without food [see Clinical Pharmacology ( 12.3 )] . Swallow tablets whole, do not crush, divide, or chew.

2.3Recommended Dosage for Treatment of Agitation Associated with Dementia Due to Alzheimer’s Disease The recommended titration schedule is as follows: The recommended starting dose is AUVELITY 30 mg/105 mg once daily, in the morning. On day 8, increase to AUVELITY 30 mg/105 mg twice daily, given at least 8 hours apart, based on tolerability. On day 15, after starting AUVELITY, increase to the maximum recommended dosage of 45 mg/105 mg twice daily, given at least 8 hours apart, based on tolerability.

Do not exceed two doses within the same day. Administer AUVELITY orally with or without food [see Clinical Pharmacology ( 12.3 )]. Swallow tablets whole, do not crush, divide, or chew.

2.4Dosage Recommendations in Patients with Renal Impairment For patients with moderate renal impairment (eGFR 30 to 59 mL/minute/1.73 m²), the dosing recommendations for AUVELITY are as follows: For patients with MDD, the recommended starting and maximum dosage is 45 mg/105 mg once daily in the morning [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )]. For patients with Agitation Associated with Dementia due to Alzheimer’s Disease, the recommended starting dosage is 30 mg/105 mg once daily in the morning.

On day 8, increase to the maximum recommended dosage of 45 mg/105 mg once daily in the morning, based on tolerability [see Use in Specific Populations ( 8.6 ), Clinical Ph…

💊 Dosage Forms and Strengths 68 words ▾

3 DOSAGE FORMS AND STRENGTHS AUVELITY extended-release tablets are available in two strengths: 30 mg dextromethorphan hydrobromide/105 mg bupropion hydrochloride. The tablets are white and round with “AXS” above “30” debossed on one side 45 mg dextromethorphan hydrobromide/105 mg bupropion hydrochloride. The tablets are beige and round with “45/105” debossed on one side Extended-release tablets: dextromethorphan hydrobromide/ bupropion hydrochloride 45 mg/105 mg, 30 mg/105 mg.

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⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS AUVELITY is contraindicated in patients: with a seizure disorder [see Warnings and Precautions ( 5.2 )] . with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate-release formulation of bupropion [see Warnings and Precautions ( 5.2 )] . undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 )] . taking, or within 14 days of stopping, MAOIs due to the risk of serious and possibly fatal drug interactions, including hypertensive crisis and serotonin syndrome [see Dosage and Administration ( 2.7 ), Warnings and Precautions ( 5.8 ), Drug Interactions ( 7.1 )] .

Starting AUVELITY in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated. with known hypersensitivity to bupropion, dextromethorphan, or other components of AUVELITY. Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported with bupropion. Arthralgia, myalgia, fever with rash, and other serum sickness-like symptoms suggestive of delayed hypersensitivity have also been reported with bupropion [see Adverse Reactions ( 6.2 )] .

Seizure disorder. ( 4 ) Current or prior diagnosis of bulimia or anorexia nervosa. ( 4 ) Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs.

( 4 ) Use with an MAOI or within 14 days of stopping treatment with AUVELITY. Do not use AUVELITY within 14 days of discontinuing an MAOI. ( 4 ) Known hypersensitivity to bupropion, dextromethorphan, or other components of AUVELITY.

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⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Seizure: Risk is dose-related. Discontinue if seizure occurs. ( 4 , 5.2 ) Increased Blood Pressure and Hypertension: AUVELITY can increase blood pressure and cause hypertension.

Assess blood pressure before initiating treatment and monitor periodically during treatment. ( 5.3 ) Activation of Mania or Hypomania: Screen patients for bipolar disorder. ( 5.4 ) Psychosis and Other Neuropsychiatric Reactions: Instruct patients to contact a healthcare provider if such reactions occur.

( 5.5 ) Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.6 ) Dizziness: AUVELITY may cause dizziness. Take precautions to reduce falls and use caution when operating machinery.

( 5.7 ) Serotonin Syndrome: Use of AUVELITY with selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants increases the risk. Discontinue if occurs. ( 5.8 , 7.1 ) Embryo-fetal Toxicity: May cause fetal harm.

Advise pregnant females of the potential risk to a fetus. Discontinue treatment in pregnant females and use alternative treatment for females who are planning to become pregnant. ( 5.9 , 8.1 , 8.3 ) Hyponatremia: Can occur in association with SIADH.

( 5.10 )

5.1Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.

There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1. Table 1: Risk Differences of the Number of Patients of Suicidal Thoughts and Behavior in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric* and Adult Patients *AUVELITY is not approved for use in pediatric patients.

Age Range Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 years old 14 additional patients 18-24 years old 5 additional patients Decreases Compared to Placebo 25-64 years old 1 fewer patient ≥65 years old 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance studies in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors.

Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing AUVELITY, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

5.2Seizure Bupropion, a component of AUVELITY, can cause seizure. The risk of seizure with bupropion is dose-related. When a bupropion hydrochloride (HCl) sustained-release tablet was dosed up to 300 mg per day (approximately 1.5 times the maximum recommended daily dosage of AUVELITY), the incidence of seizure was approximately 0.1% (1/…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions ( 5.1 )] Seizure [see Warnings and Precautions ( 5.2 )] Increased Blood Pressure and Hypertension [see Warnings and Precautions ( 5.3 )] Activation of Mania or Hypomania [see Warnings and Precautions ( 5.4 )] Psychosis and Other Neuropsychiatric Reactions [see Warnings and Precautions ( 5.5 )] Angle-closure Glaucoma [see Warnings and Precautions ( 5.6 )] Dizziness [see Warnings and Precautions ( 5.7 )] Serotonin Syndrome [see Warnings and Precautions ( 5.8 )] Embryo-fetal Toxicity [see Warnings and Precautions ( 5.9 )] Hyponatremia [see Warnings and Precautions ( 5.10 )] MDD: Most common adverse reactions (≥5% and more than twice as frequently as placebo): dizziness, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, and hyperhidrosis.

(6.1) Agitation associated with dementia due to Alzheimer’s disease: Most common adverse reactions (≥5% and more than twice as frequently as placebo): dizziness and dyspepsia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Axsome Therapeutics at 1-800-484-1672 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. AUVELITY has been evaluated for safety in 2,550 adult patients who participated in multiple-dose clinical trials for major depressive disorder, agitation associated with dementia due to Alzheimers disease, or another indication.

Among them, 918 patients were treated with AUVELITY for at least 6 months, and 251 patients were treated with AUVELITY for at least 1 year. Major Depressive Disorder The data below are based on the 6-week, placebo-controlled study in which either AUVELITY (n=162) or placebo (n=164) was administered twice daily to patients with MDD (Study 1). Demographics of the patients who participated in this study are summarized in Clinical Studies [see Clinical Studies (Section 14.1 )].

Adverse Reactions Leading to Discontinuation In the 6-week placebo-controlled study, 4% of patients treated with AUVELITY and 0% of placebo-treated patients discontinued participation due to adverse reactions. The adverse reaction that led to study discontinuation in 1% of patients treated with AUVELITY was anxiety (2%). Most Common Adverse Reactions In the 6-week placebo-controlled clinical study, the most common (incidence 5% for AUVELITY and more than twice as frequently as placebo) adverse reactions were dizziness (16%), headache (8%), diarrhea (7%), somnolence (7%), dry mouth (6%), sexual dysfunction (6%), and hyperhidrosis (5%).

Table 2 shows the incidence of adverse reactions that occurred in 2% of patients treated with AUVELITY and more frequently than in patients treated with placebo in Study 1. Table 2: Adverse Reactions Occurring in ≥2% of Adult Patients with MDD Treated with AUVELITY and More Frequently than in Patients Treated with Placebo in a 6-Week Placebo-Controlled Study (Study 1) a Sexual dysfunction includes orgasm abnormal, erectile dysfunction, libido decreased, anorgasmia b Fatigue includes fatigue, lethargy c Paraesthesia includes paraesthesia, hypoaesthesia Adverse Reaction AUVELITY (N=162) % Placebo (N=164) % Dizziness 16 6 Nausea 13 9 Headache 8 4 Diarrhea 7 3 Somnolence 7 3 Dry mouth 6 2 Sexual dysfunction a 6 0 Hyperhidrosis 5 0 Anxiety 4 1 Constipation 4 2 Decreased appetite 4 1 Insomnia 4 2 Arthralgia 3 0 Fatigue b 3 2 Paraesthesia c 3 0 Vision blurred 3 0 Agitation Associated with Dementia Due to Alzheimers Disease The data below are based on the 5-week, placebo-controlled, parallel-group study in which either AUVELITY (n=159) or placebo (n=1…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Strong CYP2D6 inhibitors: For patients with MDD or agitation associated with dementia due to Alzheimer’s disease, maximum recommended dosage is one tablet of 45 mg dextromethorphan hydrobromide/105 mg bupropion hydrochloride by mouth once daily in the morning. ( 2.5 , 7.1 ) Strong CYP2B6 inducers: Avoid use. ( 7.1 ) CYP2D6 Substrates: Increases the exposures of drugs that are substrates of CYP2D6.

( 7.1 ) Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels. ( 7.1 ) Drugs that lower seizure threshold: Coadministration may increase risk of seizure.

( 7.1 ) Dopaminergic drugs: Central Nervous System (CNS) toxicity can occur with concomitant use. ( 7.1 ) Drug-laboratory test interactions: AUVELITY can cause false-positive urine test results for amphetamines. ( 7.2 )

7.1Drugs Having Clinically Important Interactions with AUVELITY Table 4: Clinically Important Drug Interactions with AUVELITY Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of AUVELITY with MAOIs increases the risk of hypertensive crisis and serotonin syndrome. Intervention AUVELITY is contraindicated in patients taking MAOIs (including MAOIs such as linezolid or intravenous methylene blue) or in patients who have taken MAOIs within the preceding 14 days. Allow at least 14 days after stopping AUVELITY before starting an MAOI [see Dosage and Administration ( 2.7 ), Contraindications ( 4 ), Warnings and Precautions ( 5.3 , 5.8 )] Serotonergic Drugs Clinical Impact Concomitant use of AUVELITY with other serotonergic drugs increases the risk of serotonin syndrome.

Intervention Monitor for symptoms of serotonin syndrome when AUVELITY is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin syndrome occurs, consider discontinuation of AUVELITY and/or concomitant serotonergic drug [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.8 )] . Drugs that Lower Seizure Threshold Clinical Impact AUVELITY contains bupropion which can cause seizure.

Co-administration with other drugs that lower seizure threshold may increase risk of seizure. Intervention Use caution when administering AUVELITY concomitantly with drugs that lower the seizure threshold [see Warnings and Precautions ( 5.2 )] . Discontinue AUVELITY and do not restart treatment if the patient experiences a seizure.

Strong Inhibitors of CYP2D6 Clinical Impact Concomitant use of AUVELITY with strong CYP2D6 inhibitors increases plasma concentrations of dextromethorphan. Intervention Dosage adjustment is necessary when AUVELITY is co-administered with strong inhibitors of CYP2D6 [see Dosage and Administration ( 2.5 )] . Monitor patients for adverse reactions potentially attributable to dextromethorphan, such as somnolence and dizziness.

Strong Inducers of CYP2B6 Clinical Impact Concomitant use of AUVELITY with strong CYP2B6 inducers decreases plasma concentrations of dextromethorphan and bupropion and may decrease efficacy of AUVELITY [see Clinical Pharmacology ( 12.3 )] . Intervention Avoid co-administration of AUVELITY with strong inducers of CYP2B6. Consider alternatives to strong CYP2B6 inducers if needed.

Drugs Metabolized by CYP2D6 Clinical Impact CYP2D6 Substrates Coadministration of AUVELITY with drugs that are metabolized by CYP2D6 can increase the exposures of drugs that are substrates of CYP2D6. Drugs that Require Metabolic Activation by CYP2D6 Drugs that require metabolic activation by CYP2D6 to be effective could have reduced efficacy when administered concomitantly with AUVELITY. Intervention CYP2D6 Substrates When used concomitantly with AUVELITY, it may be necessary to decrease the dose of CYP2D6 substrates, particularly for drugs with a narrow therapeutic index.

Drugs that Require Metabolic Activation by CYP2D6 Patients treated concomitantly with AUVELITY may require increased doses of drugs that require activation by CYP2D6 to be effective. Digoxin Clinical Impact Coadministration…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding not recommended. ( 8.2 ) Severe Hepatic Impairment: Avoid use. ( 8.7 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including AUVELITY, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or online at: https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/ . Risk Summary Based on animal studies, AUVELITY may cause fetal harm when administered during pregnancy.

AUVELITY is not recommended during pregnancy. If a female becomes pregnant while being treated with AUVELITY, discontinue treatment and counsel the patient about the potential risk to a fetus [see Warnings and Precautions ( 5.9 )] . In oral studies conducted in rats and rabbits, a combination of dextromethorphan/quinidine demonstrated developmental toxicity, including fetal malformations (rabbits) and embryolethality, when given to pregnant animals.

When bupropion alone was administered to pregnant rats during organogenesis, there was no evidence of fetal malformations at doses up to approximately 21 times the maximum recommended human dose (MRHD) of 210 mg/day. When bupropion alone was given to pregnant rabbits during organogenesis, non-dose–related increases in incidence of fetal malformations, and skeletal variations were observed at doses approximately 2 to 5 times the MRHD and greater. Decreased fetal weights were seen at bupropion doses approximately 5 times the MRHD and greater.

Neurotoxicity findings were observed in juvenile rats treated with a combination of dextromethorphan/quinidine on postnatal day (PND) 7, which corresponds to the third trimester of gestation through the first few months of life and may extend through the first three years of life in humans. Based on these findings, AUVELITY may cause fetal harm when administered to pregnant women (see Data ) . The available clinical data on the use of AUVELITY during pregnancy is insufficient to evaluate for a drug-associated risk of major birth malformations, miscarriage, or other adverse maternal or fetal outcomes.

However, there are available data on one of the individual components of AUVELITY, bupropion. Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester have not identified an increased risk of congenital malformations overall (see Data ) . There are risks to the mother associated with untreated depression in pregnancy (see Clinical Considerations ) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants during pregnancy at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks to the mother of untreated depression and potential effects on the fetus when discontinuing or changing treatment with antidepressant medications during pregnancy and postpartum.

Data Human Data Bupropion Data from the international bupropion Pregnancy Registry (675 first trimester exposures) and a retrospective cohort study using the United Healthcare database (1,213 first trimester exposures) did not show an increased risk for malformations overall. The Registry was not designed or powered to evaluate spe…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including AUVELITY, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or online at: https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/ . Risk Summary Based on animal studies, AUVELITY may cause fetal harm when administered during pregnancy.

AUVELITY is not recommended during pregnancy. If a female becomes pregnant while being treated with AUVELITY, discontinue treatment and counsel the patient about the potential risk to a fetus [see Warnings and Precautions ( 5.9 )] . In oral studies conducted in rats and rabbits, a combination of dextromethorphan/quinidine demonstrated developmental toxicity, including fetal malformations (rabbits) and embryolethality, when given to pregnant animals.

When bupropion alone was administered to pregnant rats during organogenesis, there was no evidence of fetal malformations at doses up to approximately 21 times the maximum recommended human dose (MRHD) of 210 mg/day. When bupropion alone was given to pregnant rabbits during organogenesis, non-dose–related increases in incidence of fetal malformations, and skeletal variations were observed at doses approximately 2 to 5 times the MRHD and greater. Decreased fetal weights were seen at bupropion doses approximately 5 times the MRHD and greater.

Neurotoxicity findings were observed in juvenile rats treated with a combination of dextromethorphan/quinidine on postnatal day (PND) 7, which corresponds to the third trimester of gestation through the first few months of life and may extend through the first three years of life in humans. Based on these findings, AUVELITY may cause fetal harm when administered to pregnant women (see Data ) . The available clinical data on the use of AUVELITY during pregnancy is insufficient to evaluate for a drug-associated risk of major birth malformations, miscarriage, or other adverse maternal or fetal outcomes.

However, there are available data on one of the individual components of AUVELITY, bupropion. Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester have not identified an increased risk of congenital malformations overall (see Data ) . There are risks to the mother associated with untreated depression in pregnancy (see Clinical Considerations ) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants during pregnancy at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks to the mother of untreated depression and potential effects on the fetus when discontinuing or changing treatment with antidepressant medications during pregnancy and postpartum.

Data Human Data Bupropion Data from the international bupropion Pregnancy Registry (675 first trimester exposures) and a retrospective cohort study using the United Healthcare database (1,213 first trimester exposures) did not show an increased risk for malformations overall. The Registry was not designed or powered to evaluate specific defects but suggested a possible increase in cardiac malformations. No increased risk for cardiovascular malformations o…

🧒 Pediatric Use 44 words ▾

8.4Pediatric Use The safety and effectiveness of AUVELITY have not been established in pediatric patients. AUVELITY contains bupropion. Antidepressants, including bupropion, increase the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning , Warning and Precautions ( 5.1 )] .

🧓 Geriatric Use 135 words ▾

8.5Geriatric Use There were 720 patients 65 years of age and older in the clinical studies of AUVELITY for agitation associated with dementia due to Alzheimer’s disease [see Clinical Studies ( 14.2 ) ]. Of the total number of AUVELITY-treated patients in these studies, 368 were 65 to less than 75 years of age, while 352 were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects and other reported clinical experience has not identified differences in responses between geriatric and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

AUVELITY has been associated with clinically significant hyponatremia in geriatric patients, who may be at greater risk for this adverse event [see Warnings and Precautions ( 5.10 )] .

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE Human Experience There is limited clinical study experience regarding human overdosage with AUVELITY. Overdosage information is based on experience with the individual components, dextromethorphan and bupropion. Metabolism of the dextromethorphan component of AUVELITY is inhibited by the bupropion component, such that overdose due to AUVELITY might be more severe or more persistent compared to overdose of dextromethorphan alone.

Dextromethorphan Symptoms of dextromethorphan overdose include nausea, vomiting, stupor, coma, respiratory depression, seizures, tachycardia, hyperexcitability, and toxic psychosis. Other adverse effects include ataxia, nystagmus, dystonia, blurred vision, and changes in muscle reflexes. Dextromethorphan may cause serotonin syndrome, and this risk is increased by overdose, particularly if taken with other serotonergic agents, SSRIs or tricyclic antidepressants.

Bupropion Overdoses of up to 30 grams or more of bupropion (approximately 143 times the maximum recommended dose of AUVELITY) have been reported. Seizure was reported in approximately one-third of all cases. Other serious reactions reported with overdoses of bupropion alone included hallucinations, loss of consciousness, mental status changes, sinus tachycardia, ECG changes such as conduction disturbances (including QRS prolongation) or arrhythmias, clonus, myoclonus, and hyperreflexia.

Fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma, and respiratory failure have been reported mainly when bupropion was part of multiple drug overdoses. Although most patients recovered without sequelae, deaths associated with overdoses of bupropion alone have been reported in patients ingesting large doses of the drug. Multiple uncontrolled seizures, bradycardia, cardiac failure, and cardiac arrest prior to death were reported in these patients.

Overdosage Management Treatment of dextromethorphan overdosage should be directed at symptomatic and supportive measures. There are no known antidotes for bupropion. In case of an overdose, provide supportive care, including close medical supervision and monitoring.

Consider the possibility of multiple drug overdose. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs.

Induction of emesis is not recommended. Consider contacting a Poison Help Line (1-800-222-1222) or a medical toxicologist for overdosage management recommendations for AUVELITY.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dextromethorphan is an uncompetitive antagonist of the NMDA receptor (an ionotropic glutamate receptor) and a sigma-1 receptor agonist. The mechanism of dextromethorphan in the treatment of MDD and agitation associated with dementia due to Alzheimer’s disease is unclear. Bupropion increases plasma levels of dextromethorphan by competitively inhibiting cytochrome P450 2D6, which catalyzes a major biotransformation pathway for dextromethorphan.

The mechanism of action of bupropion in the treatment of MDD is unclear; however, it may be related to noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the reuptake of serotonin.

12.2Pharmacodynamics Cardiac Electrophysiology At the maximum recommended dose, AUVELITY does not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics AUVELITY is a combination of dextromethorphan and bupropion. Bupropion inhibits the metabolism of dextromethorphan via CYP2D6. Dextromethorphan when co-administered with bupropion displays nonlinear pharmacokinetics at steady state, with greater than dose-proportional changes in AUC and C max for varying doses of dextromethorphan [60 to 120 mg (0.67-1.33 times the maximum recommended dose of AUVELITY)] and less than dose-proportional changes for varying doses of bupropion [150 to 300 mg (0.71-1.43 times the maximum recommended dose of AUVELITY)].

Steady state plasma concentrations of dextromethorphan and bupropion when given as AUVELITY are achieved within 8 days. The accumulation ratios for dextromethorphan at steady state when given as AUVELITY are 20 and 32, respectively based on C max and AUC 0 ‑ 12 , compared to 1.3 and 1.4, respectively, for dextromethorphan given without bupropion. The accumulation ratios for bupropion at steady state are 1.1 and 1.5, respectively based on C max and AUC 0-12 .

Absorption The median T max of dextromethorphan and bupropion when given as AUVELITY was 3 hours and 2 hours, respectively. The C max of the hydroxybupropion metabolite occurred approximately 3 hours post-dose and was approximately 14 times the peak level of bupropion and its AUC 0-12 was about 19 times that of bupropion. The C max of the erythrohydroxybupropion and threohydroxybupropion metabolites occurred approximately 4 hours post-dose and were approximately equal to and 5 times that of bupropion, respectively.

The AUC 0-12 values were 1.2 and 7 times that of bupropion, respectively. Effect of Food AUVELITY can be taken with or without food. Dextromethorphan C max and AUC 0-12 were unchanged and decreased by 14%, respectively, and bupropion C max and AUC 0-12 were increased by 3% and 6%, respectively, when AUVELITY was administered with food.

Distribution The plasma protein binding of dextromethorphan is approximately 60-70% and bupropion is 84%. The extent of protein binding of the hydroxybupropion metabolite is similar to that for bupropion; whereas, the extent of protein binding of the threohydroxybupropion metabolite is about half that seen with bupropion. Elimination Following 8 days of administration of AUVELITY in extensive metabolizers, the mean elimination half-life of dextromethorphan was increased approximately 3-fold to 22 hours, as compared to dextromethorphan given without bupropion.

The mean elimination half-life of dextromethorphan and bupropion was 22 hours and 15 hours, respectively. The apparent elimination half-life of hydroxybupropion, erythrohydroxybupropion and threohydroxybupropion metabolites were approximately 35, 44 and 33 hours, respectively. Metabolism Dextromethorphan is primarily metabolized by CYP2D6 to dextrorphan.

Bupropion is extensively metabolized with three active metabolites: hydroxybupropion, which is formed via hydroxylation of the tert-butyl group of bupropion, and the amino-alcohol isomers, threohydroxybupropion…

🧬 Mechanism of Action 110 words ▾

12.1Mechanism of Action Dextromethorphan is an uncompetitive antagonist of the NMDA receptor (an ionotropic glutamate receptor) and a sigma-1 receptor agonist. The mechanism of dextromethorphan in the treatment of MDD and agitation associated with dementia due to Alzheimer’s disease is unclear. Bupropion increases plasma levels of dextromethorphan by competitively inhibiting cytochrome P450 2D6, which catalyzes a major biotransformation pathway for dextromethorphan.

The mechanism of action of bupropion in the treatment of MDD is unclear; however, it may be related to noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the reuptake of serotonin.

📦 How Supplied / Storage and Handling 138 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING AUVELITY (dextromethorphan hydrobromide / bupropion hydrochloride) extended-release tablets are film-coated, round, bilayer tablets with debossing on one side. Dextromethorphan hydrobromide 30 mg/bupropion hydrochloride 105 mg tablets are white with “AXS” above “30” debossed on one side. Dextromethorphan hydrobromide 45mg/bupropion hydrochloride 105 mg tablets are beige with “45/105” debossed on one side.

Auvelity is supplied in the following packaging configurations: Titration Pack for agitation associated with dementia due to Alzheimer’s disease, NDC 81968-345-01, containing: AUVELITY 30 mg/105 mg: one bottle of 21 tablets AUVELITY 45 mg/105 mg: one bottle of 30 tablets Auvelity 45 mg/105 mg: Bottles of 30 tablets, NDC 81968-045-30 Bottles of 60 tablets, NDC 81968-045-60 Store AUVELITY in original bottle at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description ~1 min read ▾

11 DESCRIPTION AUVELITY is a combination of dextromethorphan hydrobromide, an uncompetitive NMDA receptor antagonist and sigma-1 receptor agonist, and bupropion hydrochloride, an aminoketone and CYP450 2D6 inhibitor. The chemical name of dextromethorphan hydrobromide is morphinan, 3- methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C 18 H 25 NO•HBr•H 2 O and a molecular weight of 370.33 (271.4 dextromethorphan base).

The structural formula is: Dextromethorphan hydrobromide powder is white or almost white, crystalline, and sparingly soluble in water. The chemical name of bupropion hydrochloride is:(±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1­propanone hydrochloride. Bupropion hydrochloride has the empirical formula C 13 H 18 ClNO•HCl and a molecular weight of 276.2 (239.74 bupropion base).

The structural formula is: Bupropion hydrochloride powder is white and highly soluble in water. AUVELITY is for oral administration and is available as round bilayer tablets. Each tablet contains either 30 mg or 45 mg dextromethorphan hydrobromide (equivalent to 21.99 and 32.98 mg, respectively, dextromethorphan base) in an immediate-release formulation and 105 mg bupropion hydrochloride (equivalent to 91.14 mg bupropion base) in an extended-release formulation.

Each tablet contains the following inactive ingredients: carbomer homopolymer, colloidal silicon dioxide, crospovidone, glyceryl monocaprylocaprate, l-cysteine hydrochloride monohydrate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, talc, and titanium dioxide. Beige tablets additionally contain red iron oxide and yellow iron oxide. Structural Formula - Dextromethorphan Hydrobromide Structural Formula - Bupropion Hydrochloride

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidal ideation and behavior, especially early during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning, and Warnings and Precautions ( 5.1 )] Hypersensitivity Advise patients that both immediate and delayed hypersensitivity reactions to AUVELITY could occur.

Instruct patients to seek medical attention immediately if they experience symptoms indicative of hypersensitivity, such as skin rash, pruritus, hives, chest pain, edema, shortness of breath, arthralgia, myalgia, or fever after taking AUVELITY [see Contraindications ( 4 )] . Seizure Advise patients that AUVELITY can cause seizure and that excessive use or abrupt discontinuation of alcohol, benzodiazepines, antiepileptic drugs, or sedatives/hypnotics can increase the risk. Advise patients to minimize or avoid use of alcohol.

Instruct patients to use AUVELITY as directed and to discontinue, and not restart, AUVELITY if they experience a seizure while on treatment [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 )] . Increased Blood Pressure and Hypertension Advise patients that AUVELITY can cause increased blood pressure and hypertension and that the risk is increased if used with some other medications such as MAOIs and drugs that increase dopaminergic or noradrenergic activity [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7.1 )] .

Activation of Mania or Hypomania Advise patients to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions ( 5.4 )]. Psychosis and Other Neuropsychiatric Reactions Inform patients that changes in mood including delusions, hallucinations, psychosis, concentration disturbances, paranoia, and confusion have occurred with use of bupropion, a component of AUVELITY. Instruct patients to notify a healthcare provider if they experience such symptoms [see Warnings and Precautions ( 5.5 ), Adverse Reactions ( 6.2 )] .

Angle-closure Glaucoma Patients should be advised that taking AUVELITY can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma [see Warnings and Precautions ( 5.6 )] . Dizziness Advise patients that AUVELITY may cause dizziness. Inform patients to take precautions to reduce the risk of falls, particularly for patients with motor impairment affecting gait or a history of falls.

Caution patients about operating hazardous machinery, including motor vehicles, until they know how they will be affected by AUVELITY [see Warnings and Precautions ( 5.7 ), Adverse Reactions ( 6.1 )] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of AUVELITY with SSRIs or tricyclic antidepressants. Instruct patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions ( 5.8 ), Drug Interactions ( 7.1 )] .

Embryo-fetal Toxicity Advise pregnant females and females of reproductive potential of the potential risk to a fetus [see Warning and Precautions ( 5.9 )] . Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with AUVELITY. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AUVELITY during pregnancy [see Use in Specific Populations ( 8.1 )] .

Hyponatremia Advise patients that if they are treated with diuretics, or are otherwise volume depleted, or are elderly, they may be at greater risk of developing hyponatremia while taking AUVELITY [see Warnings and Precautions ( 5.10 )…

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. AUV-USMG-002.000-20260430 Issued: 04/2026 MEDICATION GUIDE AUVELITY ® (aw - VEHL - ah- tee) (dextromethorphan hydrobromide / bupropion hydrochloride) extended-release tablets, for oral use What is the most important information I should know about AUVELITY?

AUVELITY may cause serious side effects, including: Increased risk of suicidal thoughts and actions . AUVELITY and other antidepressant medicines may increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. AUVELITY is not for use in children.

Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions.

This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider or get emergency help right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying new or worse depression feeling very agitated or restless trouble sleeping (insomnia) suicide attempts new or worse anxiety panic attacks new or worse irritability acting aggressive, being angry, or violent an extreme increase in activity and talking (mania) acting on dangerous impulses other unusual changes in behavior or mood See “What are the possible side effects of AUVELITY?” for more information about side effects.

What is AUVELITY? AUVELITY is a prescription medicine used: to treat a certain type of depression called Major Depressive Disorder (MDD) in adults. to treat agitation that may happen with dementia due to Alzheimer’s disease. AUVELITY should not be used as an “as needed” treatment for agitation that may happen with dementia due to Alzheimer’s disease.

It is not known if AUVELITY is safe and effective for use in children. The ingredients in Auvelity, bupropion and dextromethorphan, are ingredients found in some other medicines approved for other uses. AUVELITY should not be used as an “as needed” treatment for agitation that may happen with dementia due to Alzheimer’s disease.

Do not take AUVELITY if you: have or had a seizure disorder. have or had an eating disorder such as anorexia nervosa or bulimia. have recently suddenly stopped drinking alcohol or use medicines called benzodiazepines, barbiturates, or anti-seizure medicines, and you have recently suddenly stopped taking them. take a monoamine oxidase inhibitor (MAOI) have stopped taking an MAOI in the last 14 days are being treated with the antibiotic linezolid or intravenous methylene blue are allergic to dextromethorphan, bupropion, or any of the ingredients in AUVELITY.

See the end of this Medication Guide for a complete list of ingredients in AUVELITY. Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue. Do not start AUVELITY if you stopped taking an MAOI in the last 14 days.

Do not start taking an MAOI for at least 14 days after you stop treatment with AUVELITY. Before taking AUVELITY, tell your healthcare provider about all your medical conditions, including if you: have or had seizures or convulsions have or had an eating disorder have or had a head injury have had a heart attack or have heart p…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.