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Ubrelvy ubrogepant 100 mg Tablet, 1 tablet — NDC 00023-6501-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ubrelvy ubrogepant 100 mg Tablet, 1 tablet — NDC 0023-6501-01 (Billing 00023-6501-01)

by Allergan, Inc. · 1 PACKET in 1 BOX / 1 TABLET in 1 PACKET

This is a package of 1 tablet of Ubrelvy ubrogepant 100 mg Tablet from Allergan, Inc., marketed since Dec 2019 and currently FDA-listed.

NDC 00023-6501-01
🏷️ FDA NDC (as labeled) 0023-6501-01 billing pads the labeler segment with a zero
This package
Contains1 tablet Pack sizes4 compare ↓
Also priced by: Part D plans $109.18/unit — full pricing hub ↓
Product page 00023-6501-10 Also comes in: 10 tablets 0023-6501-10 16 tablets 0023-6501-16 30 tablets 0023-6501-30
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

NDC database record

One package, one record: these facts belong to NDC 0023-6501-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0023 labeler · 6501 product · 01 package
Package marketed since
Dec 23, 2019
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2027
Billing quantity
1 EA per package
Barcode (UPC-A, from the NDC)
3 0023650101 3
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0023-6501-01
Product NDC 0023-6501
11-digit billing NDC 00023650101
NCPDP billing unit EA — each (per item)
Application # NDA211765
SPL Set ID fd9f9458-fd96-4688-be3f-f77b3d1af6ab
Established class (EPC) Calcitonin Gene-related Peptide Receptor Antagonist
Mechanism of action Calcitonin Gene-related Peptide Receptor Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-12-23
Route ORAL
Dosage form TABLET
Substance UBROGEPANT

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 080589
GCN 47478
HICL code 046273
Ingredient (HICL) Ubrogepant
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3F
Therapeutic class — specific (HIC3) Antimigraine Preparations
AHFS code 28:32.12.00
AHFS class Calcitonin Gene-Related Peptide Antag.
FDB label name UBRELVY 100 MG TABLET
FDB brand name Ubrelvy
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 080589
  • GCN: 47478
  • HICL (First Databank): 046273
  • AHFS class code: 28:32.12.00
Why two NDCs? The FDA registers this code as 0023-6501-01 — a 4-4-2 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 labeler segment → 00023-6501-01. 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.

Clinical

Label name UBRELVY 100 MG TABLET Ingredient Ubrogepant
📗 Our plain-language guide HelloPharmacist
  • It treats a migraine attack in adults once it has started, with or without aura. It is not meant to prevent migraines, so it won't reduce how often you get them.
  • Swallow the tablet when a migraine starts. You can take it with or without food. If you need it, a second dose can be taken at least 2 hours after the first. Follow the dose your p...
  • The most common are nausea, sleepiness and dry mouth. Because of the sleepiness, notice how it affects you before doing anything that needs full alertness.
  • Get help right away for trouble breathing, or swelling of your face or throat, hives or rash, and stop the medicine. Also call if you notice high blood pressure or fingers or toes...
📖 Read our full Ubrogepant guide →
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.

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 $109.18 $109.18 / 1 tablet
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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00023-6501-10 0023-6501-10 Main listing 10 PACKET in 1 BOX / 1 TABLET in 1 PACKET $109.11 / ea $1,091.07 2019-12-23 — Active
00023-6501-16 0023-6501-16 16 PACKET in 1 BOX / 1 TABLET in 1 PACKET $109.11 / ea $1,745.71 2019-12-23 — Active
00023-6501-30 0023-6501-30 30 PACKET in 1 BOX / 1 TABLET in 1 PACKET — — 2019-12-23 — Active
00023-6501-01 You're viewing this 1 PACKET in 1 BOX / 1 TABLET in 1 PACKET Sample — — 2019-12-23 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 1 tablet — 1 packet in 1 box / 1 tablet in 1 packet.
How does this package differ from NDC 00023-6501-10?
Both are Ubrelvy ubrogepant 100 mg Tablet — the drug itself is identical. This page's package is the 1 tablet one, while NDC 00023-6501-10 is the 10 tablets package.
What NDC number is used to bill for this package of Ubrelvy ubrogepant 100 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ubrelvy 100 mgthis 00023-6501-01 Allergan, 1 tablet — — 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

🏛️
2019
First FDA approval
Dec 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2041
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 Dec 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 23, 2019 RLD RS ⏳ ~15.2 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 8754096 — drug substance (U-2717)
US 8754096 — drug substance (U-2717)
US 9499545 — drug substance (U-2718)
US 9833448 — method of use (U-2718)
US 9833448 — method of use (U-2718)
US 9499545 — drug substance (U-2718)
US 11717515 — method of use (U-3677)
US 12070450 — method of use (U-3992)
US 12329750 — method of use (U-4213)
US 12194030 — method of use (U-4121)
US 12194030 — method of use (U-4122)
US 11857542 — method of use (U-3786)
US 12220408 — drug product
US 12220408 — drug product
US 12458632 — drug product
US 8912210 — drug substance
US 12168004 — drug product
US 11925709 — drug product
US 12458633 — drug product
US 12168004 — drug product
US 10117836 — drug product
US 10117836 — drug product
US 11925709 — drug product
US 12310953 — drug product
US 8912210 — drug substance
US 12458633 — drug product
US 12310953 — drug product
US 12458632 — drug product
2019 2021 2023 2025 2027 2029 2031 2033 2035 2037 2039 2041
Today
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 (28)
PatentTypeUse codeExpires
US 8754096 ↗ Drug substance U-2717 Jul 19, 2032
US 8754096 ↗ Drug substance U-2717 Jul 19, 2032
US 9499545 ↗ Drug substance U-2718 Nov 10, 2031
US 9833448 ↗ Method of use U-2718 Nov 10, 2031
US 9833448 ↗ Method of use U-2718 Nov 10, 2031
US 9499545 ↗ Drug substance U-2718 Nov 10, 2031
US 11717515 ↗ Method of use U-3677 Dec 22, 2041
US 12070450 ↗ Method of use U-3992 Dec 22, 2041
US 12329750 ↗ Method of use U-4213 Dec 22, 2041
US 12194030 ↗ Method of use U-4121 Dec 22, 2041
US 12194030 ↗ Method of use U-4122 Dec 22, 2041
US 11857542 ↗ Method of use U-3786 Dec 22, 2041
US 12220408 ↗ Drug product — Jan 30, 2035
US 12220408 ↗ Drug product — Jan 30, 2035
US 12458632 ↗ Drug product — Jan 30, 2035
US 8912210 ↗ Drug substance — Dec 23, 2033
US 12168004 ↗ Drug product — Jan 30, 2035
US 11925709 ↗ Drug product — Jan 30, 2035
US 12458633 ↗ Drug product — Jan 30, 2035
US 12168004 ↗ Drug product — Jan 30, 2035
US 10117836 ↗ Drug product — Jan 30, 2035
US 10117836 ↗ Drug product — Jan 30, 2035
US 11925709 ↗ Drug product — Jan 30, 2035
US 12310953 ↗ Drug product — Jan 30, 2035
US 8912210 ↗ Drug substance — Dec 23, 2033
US 12458633 ↗ Drug product — Jan 30, 2035
US 12310953 ↗ Drug product — Jan 30, 2035
US 12458632 ↗ Drug product — Jan 30, 2035
Common questions
Is there a generic version of UBRELVY 100 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for UBRELVY 100 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Dec 2041 — 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.

What it looks like

Color white
ShapeCapsule
ImprintU;100
Size19 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 D9C330MD8B
    Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • 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 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • UNII O03S90U1F2
    A synthetic compound combining vitamin E with polyethylene glycol and succinic acid. It acts as a solubilizer and antioxidant in medicines, helping dissolve poorly water-soluble drugs and prevent degradation of active ingredients.

8 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.

Manufacturer & labeler

LabelerAllergan, Inc.
Application holderABBVIE INC
FDA applicationNDA211765 (NDA)
Labeler code00023
First marketedDec 2019
Product typeHuman Prescription Drug
Portfolio188 products on file

More NDCs from Allergan, Inc. labeler code 00023

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 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 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 72 words ▾

1 INDICATIONS AND USAGE UBRELVY is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use UBRELVY is not indicated for the preventive treatment of migraine. UBRELVY is a calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use UBRELVY is not indicated for the preventive treatment of migraine. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dose is 50 mg or 100 mg taken orally, as needed. ( 2.1 ) If needed, a second dose may be administered at least 2 hours after the initial dose. ( 2.1 ) The maximum dose in a 24-hour period is 200 mg. ( 2.1 ) Severe Hepatic or Severe Renal Impairment: Recommended dose is 50 mg; if needed, a second 50 mg dose may be taken at least 2 hours after the initial dose. ( 2.2 , 8.6 , 8.7 )

2.1Recommended Dosage The recommended dose of UBRELVY is 50 mg or 100 mg taken orally with or without food. If needed, a second dose may be taken at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg. The safety of treating more than 8 migraines in a 30-day period has not been established.

2.2Dosage Modification s Dosing modifications for concomitant use of specific drugs and for patients with hepatic or renal impairment are provided in Table 1. Table 1: Dose Modifications for Drug Interactions and for Specific Populations Dosage Modifications Initi a l Dose Second Dose a (if needed) Concomitant Drug [see Drug Interactions ( 7 )] Moderate CYP3A4 Inhibitors ( 7.1 ) 50 mg Avoid within 24 hours Weak CYP3A4 Inhibitors ( 7.1 ) 50 mg 50 mg Strong CYP3A4 Inducers ( 7.2 ) Avoid concomitant use Weak & Moderate CYP3A4 Inducers ( 7.2 ) 100 mg 100 mg BCRP and/or P-gp only Inhibitors ( 7.3 ) 50 mg 50 mg Spec i fic Populations [see Use in Specific Populations ( 8 )] Severe Hepatic Impairment (Child-Pugh Class C) ( 8.6 ) 50 mg 50 mg Severe Renal Impairment (CLcr 15-29 mL/min) ( 8.7 ) 50 mg 50 mg End-Stage Renal Disease (CLcr <15 mL/min) ( 8.7 ) Avoid use a Second dose may be taken at least 2 hours after the initial dose

💊 Dosage Forms and Strengths 50 words ▾

3 DOSAGE FORMS AND STRENGTHS UBRELVY 50 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U50” on one side. UBRELVY 100 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U100” on one side. Tablets: 50 mg and 100 mg ( 3 )

⛔ Contraindications 73 words ▾

4 CONTRAINDICATIONS UBRELVY is contraindicated: With concomitant use of strong CYP3A4 inhibitors [see Drug Interactions ( 7.1 )] In patients with a history of serious hypersensitivity to ubrogepant or any component of UBRELVY. Reactions have included anaphylaxis, dyspnea, and facial or throat edema [see Warnings and Precautions ( 5.1 )] Concomitant use with strong CYP3A4 inhibitors. ( 4 ) History of serious hypersensitivity to ubrogepant or any component of UBRELVY.

( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue UBRELVY and initiate appropriate therapy. Severe hypersensitivity reactions have included anaphylaxis and dyspnea. These reactions can occur within minutes, hours, or days after administration.

( 5.1 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur. ( 5.2 ) Raynaud’s phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur. ( 5.3 ) 5 .1 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, dyspnea, facial or throat edema, rash, urticaria, and pruritus, have been reported with use of UBRELVY.

Hypersensitivity reactions can occur minutes, hours, or days after administration. Most reactions occurred within hours after dosing and were not serious, and some reactions led to discontinuation. If a serious or severe hypersensitivity reaction occurs, discontinue UBRELVY and institute appropriate therapy [see Contraindications ( 4 ) and Adverse Reactions ( 6.2 )] .

5. 2 Hyper tension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including UBRELVY, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension.

There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment, but was most frequently reported within 7 days of therapy initiation. The CGRP antagonist was discontinued in many of the reported cases.

Monitor patients treated with UBRELVY for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of UBRELVY is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled. 5. 3 Raynaud’s Phenomenon Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including UBRELVY.

In reported cases with small molecule CGRP antagonists, symptom onset occurred a median of 1.5 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms.

UBRELVY should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypertension [see Warnings and Precautions ( 5.2 )] Raynaud’s Phenomenon [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (at least 2% and greater than placebo) were nausea and somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 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 practice. The safety of UBRELVY was evaluated in 3,624 subjects who received at least one dose of UBRELVY. In two randomized, double-blind, placebo-controlled, Phase 3 trials in adult patients with migraine (Studies 1 and 2), a total of 1,439 patients received UBRELVY 50 mg or 100 mg [see Clinical Studies ( 14 )] .

Of the UBRELVY-treated patients in these 2 studies, approximately 89% were female, 82% were White, 15% were Black, and 17% were of Hispanic or Latino ethnicity. The mean age at study entry was 41 years (range of 18-75 years). Long-term safety was assessed in 813 patients, dosing intermittently for up to 1 year in an open-label extension study.

Patients were permitted to treat up to 8 migraines per month with UBRELVY. Of these 813 patients, 421 patients were exposed to 50 mg or 100 mg for at least 6 months, and 364 patients were exposed to these doses for at least one year, all of whom treated at least two migraine attacks per month, on average. In that study, 2.5% of patients were withdrawn from UBRELVY because of an adverse reaction.

The most common adverse reaction resulting in discontinuation in the long-term safety study was nausea. Adverse reactions in Studies 1 and 2 are shown in Table 2. Table 2: Adverse Reactions Occurring in At Least 2% and at a Frequency Greater than Placebo in Studies 1 and 2 Placebo (N= 984) % UBRELVY 50 mg (N=954) % UBRELVY 100 mg (N=485) % Nausea 2 2 4 Somnolence* 1 2 3 Dry Mouth 1 <1 2 *Somnolence includes the adverse reaction-related terms sedation and fatigue.

6 . 2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of UBRELVY. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Hypersensitivity (e.g., anaphylaxis, dyspnea, facial or throat edema, rash, urticaria, and pruritus) [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] Vascular Disorders: Hypertension [see Warnings and Precautions ( 5.2 )] , Raynaud’s phenomenon [see Warnings and Precautions ( 5.3 )]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Strong CYP3A4 Inducers: Should be avoided as concomitant use will result in reduction of ubrogepant exposure. ( 2.2 , 7.2 ) For additional dose modifications for moderate or weak CYP3A4 inhibitors and inducers or BCRP and/or P-gp only inhibitors, refer to section 2.2 . ( 7.1 , 7.2 , 7.3 )

7.1CYP3A4 I nhibitors Co-administration of UBRELVY with ketoconazole, a strong CYP3A4 inhibitor, resulted in a significant increase in exposure of ubrogepant [see Clinical Pharmacology ( 12.3 ) ] . UBRELVY should not be used with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) [see Contraindication s ( 4 )] . Co-administration of UBRELVY with verapamil, a moderate CYP3A4 inhibitor, resulted in an increase in ubrogepant exposure [see Clinical Pharmacology ( 12.3 ) ] .

Dose adjustment is recommended with concomitant use of UBRELVY and moderate CYP3A4 inhibitors (e.g., cyclosporine, ciprofloxacin, fluconazole, fluvoxamine, grapefruit juice) [see Dosage and Administration ( 2.2 )] . No dedicated drug interaction study was conducted with ubrogepant and weak CYP3A4 inhibitors. Dose adjustment is recommended with concomitant use of UBRELVY with weak CYP3A4 inhibitors [see Dosage and Administration ( 2.2 )] .

7.2CYP3A4 I nducers Co-administration of UBRELVY with rifampin, a strong CYP3A4 inducer, resulted in a significant reduction in ubrogepant exposure [ s ee Clinical Pharmacology ( 12.3 ) ] . In patients taking strong CYP3A4 inducers (e.g., phenytoin, barbiturates, rifampin, St. John’s Wort), loss of ubrogepant efficacy is expected, and concomitant use should be avoided.

Co-administration of UBRELVY with moderate or weak CYP3A4 inducers was not evaluated in a clinical study. Dose adjustment is recommended with concomitant use of UBRELVY and moderate or weak CYP3A4 inducers [see Dosage and Administration ( 2.2 )] . 7 .3 BCRP and / or P-gp Only Inhibitors Ubrogepant is a substrate of BCRP and P-gp efflux transporters.

Use of BCRP and/or P-gp only inhibitors (e.g., quinidine, carvedilol, eltrombopag, curcumin) may increase the exposure of ubrogepant [ s ee Clinical Pharmacology ( 12.3 ) ] . Clinical drug interaction studies with inhibitors of these transporters were not conducted. Dose adjustment is recommended with BCRP and/or P-gp only inhibitors [see Dosage and Administration ( 2.2 ) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) Avoid use in patients with end-stage renal disease. ( 8.7 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women who become pregnant while taking UBRELVY. Patients should be encouraged to enroll by calling 1-833-277-0206 or visiting http://empresspregnancyregistry.com . Risk Summary There are no adequate data on the developmental risk associated with the use of UBRELVY in pregnant women.

In animal studies, adverse effects on embryofetal development were observed following administration of ubrogepant during pregnancy (increased embryofetal mortality in rabbits) or during pregnancy and lactation (decreased body weight in offspring in rats) at doses greater than those used clinically and which were associated with maternal toxicity ( see Data ) . In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

The estimated rate of major birth defects (2.2% -2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. Data Animal Data Oral administration of ubrogepant (0, 1.5, 5, 25, 125 mg/kg/day) to pregnant rats during the period of organogenesis resulted in no adverse effects on embryofetal development.

Plasma exposure (AUC) at the highest dose tested is approximately 45 times that in humans at the maximum recommended human dose (MRHD) of 200 mg/day. In pregnant rabbits, ubrogepant (0, 15, 45, 75, or 250 mg/kg/day) was administered orally throughout organogenesis in two separate studies. In both studies, the highest dose tested (250 mg/kg/day) was associated with maternal toxicity.

In the first study, ubrogepant produced abortion and increased embryofetal mortality in surviving litters at the high dose (250 mg/kg/day). In the second study, excessive maternal toxicity at the high dose (250 mg/kg/day) resulted in early termination and lack of fetal data for that dose group. Plasma exposure (AUC) at the highest no-effect dose (75 mg/kg/day) for adverse effects on embryofetal development in rabbit is approximately 8 times that in humans at the MRHD.

Oral administration of ubrogepant (0, 25, 60, or 160 mg/kg/day) to rats throughout gestation and lactation resulted in decreased body weight in offspring at birth and during the lactation period at the mid and high doses, which were associated with maternal toxicity. Plasma exposure (AUC) at the no-effect dose for adverse effects on pre- and postnatal development in rats (25 mg/kg/day) is approximately 15 times that in humans at the MRHD.

8.2Lactation Risk Summary Data from a lactation study in twelve healthy adult females indicate that ubrogepant is excreted in breast milk in low amounts. The estimated relative infant dose is approximately 0.15% of the maternal weight-adjusted dose, and the milk-to-plasma ratio is 0.23 (see Data ) . There are no data on the effects of ubrogepant on the breastfed infant or the effects on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for UBRELVY and any potential adverse effects on the breastfed infant from UBRELVY or from the underlying maternal condition. Data A study was conducted in twelve healthy adult lactating females who were between 24 and 34 years of age and between 1 month and 6 months postpartum. Each subject was administered a single oral dose of ubrogepant 100 mg.

Maternal plasma and breast milk were collected for 24 hours after dosing. Using a 150 mL/kg/day estimated infant milk intake, the mean estimated relative inf… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women who become pregnant while taking UBRELVY. Patients should be encouraged to enroll by calling 1-833-277-0206 or visiting http://empresspregnancyregistry.com . Risk Summary There are no adequate data on the developmental risk associated with the use of UBRELVY in pregnant women.

In animal studies, adverse effects on embryofetal development were observed following administration of ubrogepant during pregnancy (increased embryofetal mortality in rabbits) or during pregnancy and lactation (decreased body weight in offspring in rats) at doses greater than those used clinically and which were associated with maternal toxicity ( see Data ) . In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

The estimated rate of major birth defects (2.2% -2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. Data Animal Data Oral administration of ubrogepant (0, 1.5, 5, 25, 125 mg/kg/day) to pregnant rats during the period of organogenesis resulted in no adverse effects on embryofetal development.

Plasma exposure (AUC) at the highest dose tested is approximately 45 times that in humans at the maximum recommended human dose (MRHD) of 200 mg/day. In pregnant rabbits, ubrogepant (0, 15, 45, 75, or 250 mg/kg/day) was administered orally throughout organogenesis in two separate studies. In both studies, the highest dose tested (250 mg/kg/day) was associated with maternal toxicity.

In the first study, ubrogepant produced abortion and increased embryofetal mortality in surviving litters at the high dose (250 mg/kg/day). In the second study, excessive maternal toxicity at the high dose (250 mg/kg/day) resulted in early termination and lack of fetal data for that dose group. Plasma exposure (AUC) at the highest no-effect dose (75 mg/kg/day) for adverse effects on embryofetal development in rabbit is approximately 8 times that in humans at the MRHD.

Oral administration of ubrogepant (0, 25, 60, or 160 mg/kg/day) to rats throughout gestation and lactation resulted in decreased body weight in offspring at birth and during the lactation period at the mid and high doses, which were associated with maternal toxicity. Plasma exposure (AUC) at the no-effect dose for adverse effects on pre- and postnatal development in rats (25 mg/kg/day) is approximately 15 times that in humans at the MRHD.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 64 words ▾

8.5Geriatric Use In pharmacokinetic studies, no clinically significant pharmacokinetic differences were observed between elderly and younger subjects. Clinical studies of UBRELVY did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

🆘 Overdosage 36 words ▾

10 OVERDOS AG E The elimination half-life of ubrogepant is approximately 5 to 7 hours; therefore, monitoring of patients after overdose with UBRELVY should continue for at least 24 hours, or while symptoms or signs persist.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ubrogepant is a calcitonin gene-related peptide receptor antagonist.

12.2Pharmacodynamics Cardiac Electrophysiology At a dose 2 times the maximum recommended daily dose, UBRELVY does not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics Absorption Following oral administration of UBRELVY, ubrogepant is absorbed with peak plasma concentrations at approximately 1.5 hours. Ubrogepant displays dose-proportional pharmacokinetics within the recommended dose range [see Dosage and Administration ( 2.1 )] . Effect of Food When UBRELVY was administered with a high-fat meal, the time to maximum ubrogepant plasma concentration was delayed by 2 hours and resulted in a 22% reduction in C max with no change in AUC.

UBRELVY was administered without regard to food in clinical efficacy studies [see Dosage and Administration ( 2.1 )] . Distribution Plasma protein binding of ubrogepant is 87% in vitro. The mean apparent central volume of distribution of ubrogepant (V/F) after single dose oral administration is approximately 350 L.

Elimination Metabolism Ubrogepant is eliminated mainly through metabolism, primarily by CYP3A4. The parent compound (ubrogepant), and 2 glucuronide conjugate metabolites were the most prevalent circulating components in human plasma. The glucuronide metabolites are not expected to contribute to the pharmacological activity of ubrogepant since they were reported as about 6000-fold less potent in the CGRP receptor binding assay.

Excretion The elimination half-life of ubrogepant is approximately 5-7 hours. The mean apparent oral clearance (CL/F) of ubrogepant is approximately 87 L/hr. Ubrogepant is excreted mostly via the biliary/fecal route, while the renal route is a minor route of elimination.

Following single oral dose administration of [ 14 C]-ubrogepant to healthy male subjects, 42% and 6% of the dose was recovered as unchanged ubrogepant in feces and urine, respectively. Specific Populations Patients with Renal Impairment Population pharmacokinetic analysis based on pooled data from clinical studies was used to evaluate the effect of renal impairment characterized based on estimated creatinine clearance (CLcr) using the Cockcroft-Gault (C-G) equation. Renal impairment did not reveal a significant difference in the pharmacokinetics of ubrogepant in patients with mild or moderate renal impairment (CLcr 30-89 mL/min) relative to those with normal renal function (CLcr >90 mL/min).

Patients with severe renal impairment or ESRD (eGFR <30 mL/min) have not been studied. Dose adjustment in patients with severe renal impairment (CLcr 15-29 mL/min) is recommended based on ADME information and a conservative assumption that severe renal impairment is unlikely to cause more than a two-fold increase in exposure of ubrogepant [see Dosage and Administration ( 2.2 )] . No dosing recommendations can be made for patients with ESRD (CLcr<15 mL/min).

Patients with Hepatic Impairment In patients with pre-existing mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe hepatic impairment (Child-Pugh Class C), ubrogepant exposure was increased by 7%, 50%, and 115%, respectively. Patients with severe hepatic impairment require dose adjustments [see Dosage and Administration ( 2.2 )] . Other Specific Populations Based on a population pharmacokinetic analysis, age, sex, race, and body weight did not have a significant effect on the pharmacokinetics (C max and AUC) of ubrogepant.

Therefore, no dose adjustments are warranted based on these factors. Drug Interactions In Vitro Studies Enzymes Ubrogepant is not an inhibitor of CYP1A2, 2B6, or 3A4. Ubrogepant is a weak inhibitor of CYP2C8, 2C9, 2D6, 2C19, MAO-A, and UGT1A1.

The in vitro inhibition potential is not expected to be clinically significant. Ubrogepant is not an inducer of CYP1A2, 2B6, or 3A4 at clinically relevant concentrations. Transporters Ubrogepant is a substrate of BCRP and P-gp transport… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 12 words ▾

12.1Mechanism of Action Ubrogepant is a calcitonin gene-related peptide receptor antagonist.

📦 How Supplied / Storage and Handling 216 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied UBRELVY 50 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U50” on one side in unit-dose packets (each packet contains 1 tablet): Box of 10 Packets, NDC: 0023-6498-10 Box of 16 Packets, NDC: 0023-6498-16 Box of 30 Packets, NDC: 0023-6498-30 UBRELVY 100 mg is supplied as white to off-white capsule-shaped, biconvex tablets debossed with “U100” on one side in unit-dose packets (each packet contains 1 tablet): Box of 10 Packets, NDC: 0023-6501-10 Box of 16 Packets, NDC: 0023-6501-16 Box of 30 Packets, NDC: 0023-6501-30

16.2Storage and Handling Store between 20°C and 25°C (68°F and 77°F): excursions permitted between 15°C and 30°C (59°F and 86°F) [ see USP Controlled Room Temperature ] .

16.1How Supplied UBRELVY 50 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U50” on one side in unit-dose packets (each packet contains 1 tablet): Box of 10 Packets, NDC: 0023-6498-10 Box of 16 Packets, NDC: 0023-6498-16 Box of 30 Packets, NDC: 0023-6498-30 UBRELVY 100 mg is supplied as white to off-white capsule-shaped, biconvex tablets debossed with “U100” on one side in unit-dose packets (each packet contains 1 tablet): Box of 10 Packets, NDC: 0023-6501-10 Box of 16 Packets, NDC: 0023-6501-16 Box of 30 Packets, NDC: 0023-6501-30

📦 Storage and Handling 29 words ▾

16.2Storage and Handling Store between 20°C and 25°C (68°F and 77°F): excursions permitted between 15°C and 30°C (59°F and 86°F) [ see USP Controlled Room Temperature ] .

📋 Description 149 words ▾

11 DESCRIPTION The active ingredient of UBRELVY is ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of ubrogepant is (3' S )- N -((3 S ,5 S ,6 R )-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[ b ]pyridine-6,3'-pyrrolo[2,3- b ]pyridine]-3-carboxamide and has the following structural formula: The molecular formula is C 29 H 26 F 3 N 5 O 3 and molecular weight is 549.6. Ubrogepant is a white to off-white powder.

It is freely soluble in ethanol, methanol, acetone, and acetonitrile; and is practically insoluble in water. UBRELVY is available as tablets for oral administration containing 50 mg or 100 mg ubrogepant. The inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.

The following structural formula for UBRELVY is ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of ubrogepant is (3'S)-N-((3S,5S,6R)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3'-pyrrolo[2,3-b]pyridine]-3-carboxamide.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Hypersensitivity Reactions Inform patients about the signs and symptoms of hypersensitivity reactions and that these reactions can occur with UBRELVY. Advise patients to discontinue UBRELVY and seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] .

Hypertension Inform patients that hypertension can develop or pre-existing hypertension can worsen with UBRELVY, and that they should contact their healthcare providers if they experience elevation in their blood pressure [see Warnings and Precautions ( 5.2 )] . Raynaud’s Phenomenon Inform patients that Raynaud’s phenomenon can develop or worsen with UBRELVY. Advise patients to discontinue UBRELVY and contact their healthcare provider if they experience signs or symptoms of Raynaud’s phenomenon [see Warnings and Precautions ( 5.3 )] .

Drug Interactions Inform patients that UBRELVY may interact with certain other drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription medications, over-the-counter medications, or herbal products [see Contraindication s ( 4 ) and Drug Interactions ( 7.1 , 7.2 , 7.3 )] . Advise patients to inform their healthcare provider of grapefruit juice intake because a dosage modification is recommended with co-administration. Pregnancy Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant .

Encourage pregnant patients to enroll in the registry that monitors pregnancy outcomes in women exposed to UBRELVY during pregnancy [see Use in Specific Populations ( 8.1 )] . Lactation Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations ( 8.2 )] . Manufactured for: AbbVie Inc.

North Chicago, IL 60064 © 2025 AbbVie. All rights reserved. UBRELVY and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company.

20093630 June 2025

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption Following oral administration of UBRELVY, ubrogepant is absorbed with peak plasma concentrations at approximately 1.5 hours. Ubrogepant displays dose-proportional pharmacokinetics within the recommended dose range [see Dosage and Administration ( 2.1 )] . Effect of Food When UBRELVY was administered with a high-fat meal, the time to maximum ubrogepant plasma concentration was delayed by 2 hours and resulted in a 22% reduction in C max with no change in AUC.

UBRELVY was administered without regard to food in clinical efficacy studies [see Dosage and Administration ( 2.1 )] . Distribution Plasma protein binding of ubrogepant is 87% in vitro. The mean apparent central volume of distribution of ubrogepant (V/F) after single dose oral administration is approximately 350 L.

Elimination Metabolism Ubrogepant is eliminated mainly through metabolism, primarily by CYP3A4. The parent compound (ubrogepant), and 2 glucuronide conjugate metabolites were the most prevalent circulating components in human plasma. The glucuronide metabolites are not expected to contribute to the pharmacological activity of ubrogepant since they were reported as about 6000-fold less potent in the CGRP receptor binding assay.

Excretion The elimination half-life of ubrogepant is approximately 5-7 hours. The mean apparent oral clearance (CL/F) of ubrogepant is approximately 87 L/hr. Ubrogepant is excreted mostly via the biliary/fecal route, while the renal route is a minor route of elimination.

Following single oral dose administration of [ 14 C]-ubrogepant to healthy male subjects, 42% and 6% of the dose was recovered as unchanged ubrogepant in feces and urine, respectively. Specific Populations Patients with Renal Impairment Population pharmacokinetic analysis based on pooled data from clinical studies was used to evaluate the effect of renal impairment characterized based on estimated creatinine clearance (CLcr) using the Cockcroft-Gault (C-G) equation. Renal impairment did not reveal a significant difference in the pharmacokinetics of ubrogepant in patients with mild or moderate renal impairment (CLcr 30-89 mL/min) relative to those with normal renal function (CLcr >90 mL/min).

Patients with severe renal impairment or ESRD (eGFR <30 mL/min) have not been studied. Dose adjustment in patients with severe renal impairment (CLcr 15-29 mL/min) is recommended based on ADME information and a conservative assumption that severe renal impairment is unlikely to cause more than a two-fold increase in exposure of ubrogepant [see Dosage and Administration ( 2.2 )] . No dosing recommendations can be made for patients with ESRD (CLcr<15 mL/min).

Patients with Hepatic Impairment In patients with pre-existing mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe hepatic impairment (Child-Pugh Class C), ubrogepant exposure was increased by 7%, 50%, and 115%, respectively. Patients with severe hepatic impairment require dose adjustments [see Dosage and Administration ( 2.2 )] . Other Specific Populations Based on a population pharmacokinetic analysis, age, sex, race, and body weight did not have a significant effect on the pharmacokinetics (C max and AUC) of ubrogepant.

Therefore, no dose adjustments are warranted based on these factors. Drug Interactions In Vitro Studies Enzymes Ubrogepant is not an inhibitor of CYP1A2, 2B6, or 3A4. Ubrogepant is a weak inhibitor of CYP2C8, 2C9, 2D6, 2C19, MAO-A, and UGT1A1.

The in vitro inhibition potential is not expected to be clinically significant. Ubrogepant is not an inducer of CYP1A2, 2B6, or 3A4 at clinically relevant concentrations. Transporters Ubrogepant is a substrate of BCRP and P-gp transporters in-vitro; therefore, use of inhibitors of BCRP and/or P-gp may increase the exposure of ubrogepant.

Dose adjustment for concomitant use of UBRELVY with inhibitors of BCRP and/or P-gp is recommended based on ADME and clinical interaction studies with CYP3A4/P-gp inhibitors that show the highes… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 26 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology At a dose 2 times the maximum recommended daily dose, UBRELVY does not prolong the QT interval to any clinically relevant extent.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of UBRELVY for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials [Study 1 (NCT02828020) and Study 2 (NCT02867709)]. Study 1 randomized patients to placebo (n=559) or UBRELVY 50 mg (n=556) or 100 mg (n=557) and Study 2 randomized patients to placebo (n=563) or UBRELVY 50 mg (n=562). In all studies, patients were instructed to treat a migraine with moderate to severe headache pain intensity.

A second dose of study medication (UBRELVY or placebo), or the patient’s usual acute treatment for migraine, was allowed between 2 to 48 hours after the initial treatment for a non-responding or recurrent migraine headache. Up to 23% of patients were taking preventive medications for migraine at baseline. None of these patients were on concomitant preventive medication that act on the CGRP pathway.

The primary efficacy analyses were conducted in patients who treated a migraine with moderate to severe pain. The efficacy of UBRELVY was established by an effect on pain freedom at 2 hours post-dose and most bothersome symptom (MBS) freedom at 2 hours post-dose, compared to placebo, for Studies 1 and 2. Pain freedom was defined as a reduction of moderate or severe headache pain to no pain, and MBS freedom was defined as the absence of the self-identified MBS (i.e., photophobia, phonophobia, or nausea).

Among patients who selected an MBS, the most commonly selected was photophobia (56%), followed by phonophobia (24%), and nausea (19%). In both studies, the percentage of patients achieving headache pain freedom and MBS freedom 2 hours post-dose was significantly greater among patients receiving UBRELVY compared to those receiving placebo (see Table 3 ). Table 3 also presents the results of the analyses of the percentage of patients achieving pain relief at 2 hours (defined as a reduction in migraine pain from moderate or severe to mild or none) post-dose and the percentage of patients achieving sustained pain freedom between 2 to 24 hours post-dose.

The incidence of photophobia and phonophobia was reduced following administration of UBRELVY at both doses (50 mg and 100 mg) as compared to placebo. Table 3: Migraine Efficacy Endpoints for Study 1 and Study 2 Study 1 Study 2 UBRELVY 50 mg UBRELVY 100 mg Placebo UBRELVY 50 mg Placebo Pain Free at 2 hours N 422 448 456 464 456 % Responders 19.2 21.2 11.8 21.8

14.3Difference from placebo (%) 7.4 9.4 7.5 p value 0.002 <0.001 0.007 Most Bothersome Symptom Free at 2 hours N 420 448 454 463 456 % Responders 38.6 37.7 27.8 38.9

27.4Difference from placebo (%) 10.8 9.9 11.5 p value <0.001 <0.001 <0.001 P ain R elief at 2 hours N 422 448 456 464 456 % Responders 60.7 61.4 49.1 62.7 48.2 p value <0.001 <0.001 <0.001 Sustained Pain Freedom 2-24 hours N 418 441 452 457 451 % Responders 12.7 15.4 8.6 14.4 8.2 p value *NS 0.002 0.005 * Not statistically significant (NS) Figure 1 presents the percentage of patients achieving migraine pain freedom within 2 hours following treatment in Studies 1 and 2. Figure 1: Percentage of Patients Achieving Pain Freedom within 2 Hours in Pooled Studies 1 and 2 a The 100 mg arm was only included in Study 1.

Figure 2 presents the percentage of patients achieving MBS freedom within 2 hours in Studies 1 and 2. Figure 2: Percentage of Patients Achieving MBS Freedom within 2 Hours in Pooled Studies 1 and 2 a The 100 mg arm was only included in Study 1. Figure 1: Percentage of Patients Achieving Pain Freedom within 2 Hours in Pooled Studies 1 and 2 Figure 2: Percentage of Patients Achieving MBS Freedom within 2 Hours in Pooled Studies 1 and 2

🧪 Nonclinical Toxicology 183 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity Two-year oral carcinogenicity studies of ubrogepant were conducted in mice (0, 5, 15, or 50 mg/kg/day) and rats (0, 10, 30, or 100 mg/kg in males; 0, 10, 30, or 150 mg/kg in females). There was no evidence of drug-related tumors in either species. The highest dose tested in mice is similar to the maximum recommended human dose (200 mg/day) on a body surface area (mg/m 2 ) basis.

Plasma exposure (AUC) at the highest dose tested in rats is approximately 25 times that in humans at the maximum recommended human dose (MRHD) of 200 mg/day. Mutagenicity Ubrogepant was negative in in vitro (Ames, chromosomal aberration test in Chinese Hamster Ovary cells) and in vivo (rat bone marrow micronucleus) assays. Impairment of Fertility Oral administration of ubrogepant (0, 20, 80, or 160 mg/kg/day) to male and female rats (mated with drug-naïve females and males, respectively) resulted in no adverse effects on fertility or reproductive performance.

Plasma exposures (AUC) at the highest dose tested are approximately 30 times that in humans at the MRHD.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 180 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity Two-year oral carcinogenicity studies of ubrogepant were conducted in mice (0, 5, 15, or 50 mg/kg/day) and rats (0, 10, 30, or 100 mg/kg in males; 0, 10, 30, or 150 mg/kg in females). There was no evidence of drug-related tumors in either species. The highest dose tested in mice is similar to the maximum recommended human dose (200 mg/day) on a body surface area (mg/m 2 ) basis.

Plasma exposure (AUC) at the highest dose tested in rats is approximately 25 times that in humans at the maximum recommended human dose (MRHD) of 200 mg/day. Mutagenicity Ubrogepant was negative in in vitro (Ames, chromosomal aberration test in Chinese Hamster Ovary cells) and in vivo (rat bone marrow micronucleus) assays. Impairment of Fertility Oral administration of ubrogepant (0, 20, 80, or 160 mg/kg/day) to male and female rats (mated with drug-naïve females and males, respectively) resulted in no adverse effects on fertility or reproductive performance.

Plasma exposures (AUC) at the highest dose tested are approximately 30 times that in humans at the MRHD.

📄 Patient Package Insert ~3 min read ▾

Patient Information UBRELVY ® (you-brel-vee) (ubrogepant) tablets, for oral use What is UBRELVY? UBRELVY is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults. UBRELVY is not used to prevent migraine headaches.

It is not known if UBRELVY is safe and effective in children. Who should not use UBRELVY ? Do not take UBRELVY if you are taking medicines known as a strong CYP3A4 inhibitor, such as ketoconazole, clarithromycin, or itraconazole.

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take UBRELVY with other medicines. allergic to ubrogepant or any of the ingredients in UBRELVY. See the end of this Medication Guide for a complete list of ingredients in UBRELVY.

Before you take UBRELVY tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure have circulation problems in your fingers and toes have liver problems have kidney problems are pregnant or plan to become pregnant. It is not known if UBRELVY will harm your unborn baby. Pregnancy Registry: There is a pregnancy registry for women who take UBRELVY.

The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-833-277-0206 to enroll in this registry. You can also visit http://empresspregnancyregistry.com . are breastfeeding or plan to breastfeed.

Very small amounts of UBRELVY pass into breast milk. Talk with your healthcare provider if you plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take any of the following, as your healthcare provider may need to change the dose of UBRELVY: verapamil cyclosporine ciprofloxacin fluconazole fluvoxamine phenytoin barbiturates rifampin St. John’s Wort Quinidine carvedilol eltrombopag curcumin These are not all of the medicines that could affect how UBRELVY works. Your healthcare provider can tell you if it is safe to take UBRELVY with other medicines.

Keep a list of medicines you take to show to your healthcare provider or pharmacist when you get a new medicine. How should I take UBRELVY? Take UBRELVY exactly as your healthcare provider tells you to take it.

Take UBRELVY with or without food. Most patients can take a second tablet 2 hours after the first tablet, as needed. You should not take a second tablet within 24 hours if you consume grapefruit or grapefruit juice or are taking medications that may include: verapamil cyclosporine ciprofloxacin fluconazole fluvoxamine It is not known if it is safe to take UBRELVY for more than 8 migraine headaches in 30 days.

You should write down when you have headaches and when you take UBRELVY so you can talk to your healthcare provider about how UBRELVY is working for you. If you take too much UBRELVY, call your healthcare provider or go to the nearest hospital emergency room right away. What are the possible side effects of UBRELVY?

UBRELVY may cause serious side effects, including: Allergic reactions. Allergic reactions can happen after you take UBRELVY. Most reactions happened within hours and were not serious.

Some reactions may occur days after taking UBRELVY. Call your healthcare provider or get emergency help right away if you have any of the following symptoms, which may be part of an allergic reaction: ○ Swelling of the face, mouth, tongue, or throat ○ Trouble breathing High blood pressure: High blood pressure or worsening of high blood pressure can happen after you take UBRELVY. Contact your healthcare provider if you have an increase in blood pressure Raynaud’s phenomenon: A type of circulation problem can worsen or happen after you take UBRELVY.

Raynaud’s phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing c… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 9 words ▾

Warnings and Precautions ( 5.2 , 5.3 ) 3/2025

📄 Package Label / Principal Display Panel 62 words ▾

PRINCIPAL DISPLAY PANEL NDC 0023-6498-10 contains 10 tablets Rx Only UBRELVY ® (ubrogepant) tablets 50 mg PRINCIPAL DISPLAY PANEL NDC 0023-6498-10 contains 10 tablets Rx Only UBRELVY® (ubrogepant) tablets 50 mg

PRINCIPAL DISPLAY PANEL NDC 0023-6501-10 contains 10 tablets Rx Only UBRELVY ® (ubrogepant) tablets 100 mg PRINCIPAL DISPLAY PANEL NDC 0023-6501-10 contains 10 tablets Rx Only UBRELVY® (ubrogepant) tablets 100 mg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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.
10 tablets00023-6501-10 238,079 Rx · $269,791,249
16 tablets00023-6501-16 47,442 Rx · $72,925,778
30 tablets00023-6501-30 No Medicaid data
1 tablet this page00023-6501-01 No Medicaid data
Drug total (last 4 qtrs): 285,521 Rx · 3,249,244 units · $342,717,027 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 Ubrelvy — 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 Ubrelvy. 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
$155.52M
Claims incl. refills
109.4K
Beneficiaries
60.4K
Spend / beneficiary
$2,573.89
Spend / claim
$1,422.09
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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Allergan, 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 10 tablets (00023-6501-10), 16 tablets (00023-6501-16), 30 tablets (00023-6501-30). 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?
Allergan, 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.
← 00023-6499-00 · Allergan, 00023-6502-00 · Allergan, →
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.