Home › NDC Lookup › Ingredients › Sodium Oxybate › 13551-0004-30
Lumryz sodium oxybate 9 g For Suspension, Extended Release, 30 packets — NDC 13551-0004-30 package photo

Lumryz sodium oxybate 9 g For Suspension, Extended Release, 30 packets

by Avadel CNS Pharmaceuticals, LLC · 30 PACKET in 1 CARTON (13551-004-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
NDC 13551-0004-30
🏷️ FDA NDC (as labeled) 13551-004-30 billing pads the product segment with a zero
This package
Contains30 packets Pack sizes2 compare ↓
Also priced by: Part D plans $722.70/unit — full pricing hub ↓
Also comes in: 7 packets 13551-0004-07
Rx only Brand On market CIII 🛡 REMS
🗂️ Data synced Jul 24, 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) 13551-004-30
Product NDC 13551-004
11-digit billing NDC 13551000430
NCPDP billing unit EA — each (per item)
RxCUI 2636822, 2636828, 2636830, 2636832, 2636834, 2636836, 2636838, 2636840,
UNII 7G33012534
Application # NDA214755
SPL Set ID 10e5e40c-52f3-4c73-8a34-2c29c690a934
Established class (EPC) Central Nervous System Depressant
Physiologic effect Central Nervous System Depression; Decreased Central Nervous System Organized Electrical Activity
DEA schedule CIII
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-05-01
Route ORAL
Dosage form FOR SUSPENSION, EXTENDED RELEASE
Substance SODIUM OXYBATE
GCN Seq No 084722
GCN 54092
HICL code 012346
Ingredient (HICL) Sodium Oxybate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H7
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)
HIC3 code H7W
Therapeutic class — specific (HIC3) Anti-Narcolepsy,Anti-Cataplexy,Sedative-Type Agent
AHFS code 28:20.80.00
AHFS class Wakefulness-Promoting Agents
FDB label name LUMRYZ ER 9 GM PACKET
FDB brand name Lumryz
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 13551-004-30 — 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 → 13551-0004-30. 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 Central Nervous System Depressant class.

Pharmacologic class Central Nervous System Depressant
Drug family (ATC) Other general anesthetics, Other nervous system drugs
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

LabelerAvadel CNS Pharmaceuticals, LLC
Application holderAVADEL CNS PHARMACEUTICALS LLC
FDA applicationNDA214755 (NDA)
Labeler code13551
First marketedMay 2023
DEA scheduleCIII
Product typeHuman Prescription Drug
Portfolio5 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 LUMRYZ ER 9 GM PACKET Ingredient Sodium Oxybate
📗 Our plain-language guide HelloPharmacist
  • That's a great question, and the answer depends on which product you're prescribed. If you're on Xyrem or the generic oral solution, yes — you do need two doses spaced about 2.5 to...
  • Why do I have to take two doses in the middle of the night — can't I just take it all at once?
  • No — alcohol and sodium oxybate absolutely cannot be mixed, even if there are hours between them. Combining the two dramatically increases the risk of your breathing slowing down d...
  • Can I have a glass of wine with dinner if I take my dose hours later at bedtime?
📖 Read our full Sodium Oxybate 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.

💊 What it looks like

Color white
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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 mLPer 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 $722.70 —
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
Lumryz 9 gthis 13551-0004-30 Avadel 30 packets — — 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

🏛️
2023
First FDA approval
May 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2042
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 Mar 2042. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 1, 2023 RLD RS ⏳ ~15.5 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 12303478 — method of use (U-4189)
US 12303478 — method of use (U-4189)
US 12303478 — method of use (U-4189)
US 12303478 — method of use (U-4189)
US 11602513 — method of use (U-3576)
US 11602513 — method of use (U-3576)
US 11602513 — method of use (U-3576)
US 11602512 — method of use (U-3577)
US 11602512 — method of use (U-3577)
US 11602512 — method of use (U-3577)
US 11602512 — method of use (U-3577)
US 11583510 — method of use (U-3578)
US 11583510 — method of use (U-3578)
US 11583510 — method of use (U-3578)
US 11583510 — method of use (U-3578)
US 11400065 — method of use (U-3579)
US 11400065 — method of use (U-3579)
US 11400065 — method of use (U-3579)
US 11400065 — method of use (U-3579)
US 11000498 — method of use (U-3580)
US 11000498 — method of use (U-3580)
US 11000498 — method of use (U-3580)
US 11000498 — method of use (U-3580)
US 12128021 — method of use (U-4022)
US 12128021 — method of use (U-4022)
US 12128021 — method of use (U-4022)
US 12128021 — method of use (U-4022)
US 11986451 — method of use (U-3934)
US 11986451 — method of use (U-3934)
US 11986451 — method of use (U-3934)
US 11986451 — method of use (U-3934)
US 10952986 — method of use (U-3601)
US 10952986 — method of use (U-3601)
US 10952986 — method of use (U-3601)
US 10952986 — method of use (U-3601)
US 11602513 — method of use (U-3576)
US 11779557 — method of use (U-3705)
US 11779557 — method of use (U-3705)
US 11779557 — method of use (U-3705)
US 11779557 — method of use (U-3705)
US 11826335 — method of use (U-3751)
US 12097176 — method of use (U-4006)
US 12097176 — method of use (U-4006)
US 12097176 — method of use (U-4006)
US 12097176 — method of use (U-4006)
US 11896572 — drug product
US 11896572 — drug product
US 11839597 — drug product
US 12109186 — drug product
US 11766418 — drug product
US 11065224 — drug product
US 10272062 — drug product
US 12115143 — drug product
US 12115143 — drug product
US 12138239 — drug product
US 12115144 — drug product
US 12115142 — drug product
US 11504347 — drug product
US 11896572 — drug product
US 12109186 — drug product
US 10973795 — drug product
US 11839597 — drug product
US 12115142 — drug product
US 10272062 — drug product
US 12115144 — drug product
US 12097175 — drug product
US 12115145 — drug product
US 12115142 — drug product
US 11839597 — drug product
US 10973795 — drug product
US 12115143 — drug product
US 12097175 — drug product
US 12115144 — drug product
US 12138239 — drug product
US 12138239 — drug product
US 11504347 — drug product
US 12115145 — drug product
US 11766418 — drug product
US 12144793 — drug product
US 12097175 — drug product
US 12097175 — drug product
US 12144793 — drug product
US 10272062 — drug product
US 11052061 — drug product
US 10973795 — drug product
US 10736866 — drug product
US 11065224 — drug product
US 11052061 — drug product
US 11504347 — drug product
US 10736866 — drug product
US 12115145 — drug product
US 11065224 — drug product
US 11839597 — drug product
US 11052061 — drug product
US 12115143 — drug product
US 12115144 — drug product
US 12115142 — drug product
US 11065224 — drug product
US 12138239 — drug product
US 11766418 — drug product
US 10973795 — drug product
US 10736866 — drug product
US 12144793 — drug product
US 11766418 — drug product
US 12144793 — drug product
US 11896572 — drug product
US 12109186 — drug product
US 12115145 — drug product
US 12109186 — drug product
US 11504347 — drug product
US 11052061 — drug product
US 10736866 — drug product
US 10272062 — drug product
Exclusivity NP
Exclusivity ODE-431
Exclusivity ODE-494
Exclusivity NP
Exclusivity ODE-431
Exclusivity ODE-494
Exclusivity NP
Exclusivity ODE-431
Exclusivity ODE-494
Exclusivity NP
Exclusivity ODE-431
Exclusivity ODE-494
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 (113)
PatentTypeUse codeExpires
US 12303478 ↗ Method of use U-4189 Jul 21, 2037
US 12303478 ↗ Method of use U-4189 Jul 21, 2037
US 12303478 ↗ Method of use U-4189 Jul 21, 2037
US 12303478 ↗ Method of use U-4189 Jul 21, 2037
US 11602513 ↗ Method of use U-3576 Jul 21, 2037
US 11602513 ↗ Method of use U-3576 Jul 21, 2037
US 11602513 ↗ Method of use U-3576 Jul 21, 2037
US 11602512 ↗ Method of use U-3577 Jul 21, 2037
US 11602512 ↗ Method of use U-3577 Jul 21, 2037
US 11602512 ↗ Method of use U-3577 Jul 21, 2037
US 11602512 ↗ Method of use U-3577 Jul 21, 2037
US 11583510 ↗ Method of use U-3578 Feb 7, 2042
US 11583510 ↗ Method of use U-3578 Feb 7, 2042
US 11583510 ↗ Method of use U-3578 Feb 7, 2042
US 11583510 ↗ Method of use U-3578 Feb 7, 2042
US 11400065 ↗ Method of use U-3579 Jul 21, 2037
US 11400065 ↗ Method of use U-3579 Jul 21, 2037
US 11400065 ↗ Method of use U-3579 Jul 21, 2037
US 11400065 ↗ Method of use U-3579 Jul 21, 2037
US 11000498 ↗ Method of use U-3580 Jul 21, 2037
US 11000498 ↗ Method of use U-3580 Jul 21, 2037
US 11000498 ↗ Method of use U-3580 Jul 21, 2037
US 11000498 ↗ Method of use U-3580 Jul 21, 2037
US 12128021 ↗ Method of use U-4022 Jul 21, 2037
US 12128021 ↗ Method of use U-4022 Jul 21, 2037
US 12128021 ↗ Method of use U-4022 Jul 21, 2037
US 12128021 ↗ Method of use U-4022 Jul 21, 2037
US 11986451 ↗ Method of use U-3934 Jul 21, 2037
US 11986451 ↗ Method of use U-3934 Jul 21, 2037
US 11986451 ↗ Method of use U-3934 Jul 21, 2037
US 11986451 ↗ Method of use U-3934 Jul 21, 2037
US 10952986 ↗ Method of use U-3601 Jul 21, 2037
US 10952986 ↗ Method of use U-3601 Jul 21, 2037
US 10952986 ↗ Method of use U-3601 Jul 21, 2037
US 10952986 ↗ Method of use U-3601 Jul 21, 2037
US 11602513 ↗ Method of use U-3576 Jul 21, 2037
US 11779557 ↗ Method of use U-3705 Mar 16, 2042
US 11779557 ↗ Method of use U-3705 Mar 16, 2042
US 11779557 ↗ Method of use U-3705 Mar 16, 2042
US 11779557 ↗ Method of use U-3705 Mar 16, 2042
US 11826335 ↗ Method of use U-3751 Jul 21, 2037
US 12097176 ↗ Method of use U-4006 Jul 21, 2037
US 12097176 ↗ Method of use U-4006 Jul 21, 2037
US 12097176 ↗ Method of use U-4006 Jul 21, 2037
US 12097176 ↗ Method of use U-4006 Jul 21, 2037
US 11896572 ↗ Drug product — Jul 21, 2037
US 11896572 ↗ Drug product — Jul 21, 2037
US 11839597 ↗ Drug product — Jul 21, 2037
US 12109186 ↗ Drug product — Jul 21, 2037
US 11766418 ↗ Drug product — Jul 21, 2037
US 11065224 ↗ Drug product — Jul 21, 2037
US 10272062 ↗ Drug product — Jul 21, 2037
US 12115143 ↗ Drug product — Jul 21, 2037
US 12115143 ↗ Drug product — Jul 21, 2037
US 12138239 ↗ Drug product — Jul 21, 2037
US 12115144 ↗ Drug product — Jul 21, 2037
US 12115142 ↗ Drug product — Jul 21, 2037
US 11504347 ↗ Drug product — Jul 21, 2037
US 11896572 ↗ Drug product — Jul 21, 2037
US 12109186 ↗ Drug product — Jul 21, 2037
US 10973795 ↗ Drug product — Jul 21, 2037
US 11839597 ↗ Drug product — Jul 21, 2037
US 12115142 ↗ Drug product — Jul 21, 2037
US 10272062 ↗ Drug product — Jul 21, 2037
US 12115144 ↗ Drug product — Jul 21, 2037
US 12097175 ↗ Drug product — Jul 21, 2037
US 12115145 ↗ Drug product — Jul 21, 2037
US 12115142 ↗ Drug product — Jul 21, 2037
US 11839597 ↗ Drug product — Jul 21, 2037
US 10973795 ↗ Drug product — Jul 21, 2037
US 12115143 ↗ Drug product — Jul 21, 2037
US 12097175 ↗ Drug product — Jul 21, 2037
US 12115144 ↗ Drug product — Jul 21, 2037
US 12138239 ↗ Drug product — Jul 21, 2037
US 12138239 ↗ Drug product — Jul 21, 2037
US 11504347 ↗ Drug product — Jul 21, 2037
US 12115145 ↗ Drug product — Jul 21, 2037
US 11766418 ↗ Drug product — Jul 21, 2037
US 12144793 ↗ Drug product — Jul 21, 2037
US 12097175 ↗ Drug product — Jul 21, 2037
US 12097175 ↗ Drug product — Jul 21, 2037
US 12144793 ↗ Drug product — Jul 21, 2037
US 10272062 ↗ Drug product — Jul 21, 2037
US 11052061 ↗ Drug product — Jul 21, 2037
US 10973795 ↗ Drug product — Jul 21, 2037
US 10736866 ↗ Drug product — Jul 21, 2037
US 11065224 ↗ Drug product — Jul 21, 2037
US 11052061 ↗ Drug product — Jul 21, 2037
US 11504347 ↗ Drug product — Jul 21, 2037
US 10736866 ↗ Drug product — Jul 21, 2037
US 12115145 ↗ Drug product — Jul 21, 2037
US 11065224 ↗ Drug product — Jul 21, 2037
US 11839597 ↗ Drug product — Jul 21, 2037
US 11052061 ↗ Drug product — Jul 21, 2037
US 12115143 ↗ Drug product — Jul 21, 2037
US 12115144 ↗ Drug product — Jul 21, 2037
US 12115142 ↗ Drug product — Jul 21, 2037
US 11065224 ↗ Drug product — Jul 21, 2037
US 12138239 ↗ Drug product — Jul 21, 2037
US 11766418 ↗ Drug product — Jul 21, 2037
US 10973795 ↗ Drug product — Jul 21, 2037
US 10736866 ↗ Drug product — Jul 21, 2037
US 12144793 ↗ Drug product — Jul 21, 2037
US 11766418 ↗ Drug product — Jul 21, 2037
US 12144793 ↗ Drug product — Jul 21, 2037
US 11896572 ↗ Drug product — Jul 21, 2037
US 12109186 ↗ Drug product — Jul 21, 2037
US 12115145 ↗ Drug product — Jul 21, 2037
US 12109186 ↗ Drug product — Jul 21, 2037
US 11504347 ↗ Drug product — Jul 21, 2037
US 11052061 ↗ Drug product — Jul 21, 2037
US 10736866 ↗ Drug product — Jul 21, 2037
US 10272062 ↗ Drug product — Jul 21, 2037
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductMay 1, 2026
ODE-431Orphan Drug Exclusivity (7-year)May 1, 2030
ODE-494Orphan Drug Exclusivity (7-year)Oct 16, 2031
NPNew ProductMay 1, 2026
ODE-431Orphan Drug Exclusivity (7-year)May 1, 2030
ODE-494Orphan Drug Exclusivity (7-year)Oct 16, 2031
NPNew ProductMay 1, 2026
ODE-431Orphan Drug Exclusivity (7-year)May 1, 2030
ODE-494Orphan Drug Exclusivity (7-year)Oct 16, 2031
NPNew ProductMay 1, 2026
ODE-431Orphan Drug Exclusivity (7-year)May 1, 2030
ODE-494Orphan Drug Exclusivity (7-year)Oct 16, 2031
Common questions
Is there a generic version of LUMRYZ ER 9 GM PACKET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for LUMRYZ ER 9 GM PACKET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Mar 2042 — 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.

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

Medicare Part D (outpatient prescription) spending for Lumryz — 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 Lumryz. 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
$10.79M
Claims incl. refills
608
Beneficiaries
250
Spend / beneficiary
$43,175.82
Spend / claim
$17,753.22
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.
🛡
This drug has a REMS — LUMRYZ REMS. A Risk Evaluation & Mitigation Strategy is an FDA-required safety program. It is available only through a restricted program (certified prescribers/pharmacies, enrollment, or required monitoring). See the boxed warning & full label below, and REMS@FDA ↗.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
13551-0004-07 7 PACKET in 1 CARTON (13551-004-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET 2023-05-01 Active
13551-0004-30 You're viewing this 30 PACKET in 1 CARTON (13551-004-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET 2023-05-01 Active

Pack size FAQ

What quantity is in NDC 13551-0004-30?
NDC 13551-0004-30 contains 30 packets — 30 packet in 1 carton / 1 for suspension, extended release in 1 packet.
What is the difference between NDC 13551-0004-30 and NDC 13551-0004-07?
Both are Lumryz sodium oxybate 9 g For Suspension, Extended Release — the drug itself is identical. NDC 13551-0004-30 is the 30 packets package, while NDC 13551-0004-07 is the 7 packets package.
What NDC number is used to bill for this package of Lumryz sodium oxybate 9 g For Suspension, Extended Release?
Bill NDC 13551-0004-30 — the 11-digit billing format is 13551000430. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 13551-004-30, 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: 13551-0004-30, written without dashes as 13551000430. 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 13551-0004-30, the first segment (13551) is the labeler code FDA assigned to Avadel CNS Pharmaceuticals, LLC; the middle segment (0004) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 Avadel CNS Pharmaceuticals, LLC. 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 1 other package presentation of this same product, including 7 packets (13551-0004-07). 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?
Avadel CNS Pharmaceuticals, LLC 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION AND ABUSE AND MISUSE Central Nervous System Depression LUMRYZ (sodium oxybate) is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with LUMRYZ at recommended doses [see Warnings and Precautions (5.1) ] . Many patients who received sodium oxybate during clinical trials in narcolepsy were receiving central nervous system stimulants [see Clinical Trials (14) ] .

Abuse and Misuse LUMRYZ (sodium oxybate) is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death [see Warnings and Precautions (5.2) ] . Because of the risks of CNS depression and abuse and misuse, LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the LUMRYZ REMS [see Warnings and Precautions (5.3) ].

WARNING: CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION AND ABUSE AND MISUSE See full prescribing information for complete boxed warning. Central Nervous System Depression • LUMRYZ is a CNS depressant, and respiratory depression can occur with LUMRYZ use ( 5.1 , 5.4 ) Abuse and Misuse • LUMRYZ is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB is associated with CNS adverse reactions, including seizure, respiratory depression, decreased consciousness, coma, and death ( 5.2 , 9.2 ) LUMRYZ is available only through a restricted program called the LUMRYZ REMS ( 5.3 )

🎯 Indications and Usage 58 words ▾

1 INDICATIONS AND USAGE LUMRYZ is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. LUMRYZ is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy ( 1 ).

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Dosing for Adults: • Initiate dosage at 4.5 g once per night orally ( 2.1 ). • Titrate to effect in increments of 1.5 g per night at weekly intervals ( 2.1 ). • Recommended dosage range: 6 g to 9 g once per night orally ( 2.1 ). Dosing for Pediatric Patients (7 Years of Age and Older): • The recommended starting dosage, titration regimen, and maximum total nightly dosage are based on body weight ( 2.2 ) • Pediatric patients 7 years and older weighing at least 45 kg : The recommended starting dosage is 4.5 g once per night.

Increase the dosage by 1.5 g per night at weekly intervals to the maximum recommended dosage of 9 g once per night orally. The dosage may be gradually titrated based on efficacy and tolerability ( 2.2 ). • Pediatric patients 7 years and older weighing less than 45 kg : Because the recommended starting dosage cannot be achieved with the available strengths of LUMRYZ, use another sodium oxybate product to initiate treatment ( 2.2 ). Important Administration Information • Prepare the dose of LUMRYZ prior to bedtime; suspend dose in approximately ⅓ cup of water (with or without calorie-free drink mix or flavored water enhancer) in the mixing cup provided ( 2.3 ). • Allow 2 hours after eating before dosing ( 2.3 ). • Take LUMRYZ while in bed and lie down after dosing ( 2.3 ).

2.1Adult Dosing Information The recommended starting dosage of LUMRYZ in adults is 4.5 grams (g) once per night administered orally. Increase the dosage by 1.5 g per night at weekly intervals to the recommended dosage range of 6 g to 9 g once per night orally. The dosage may be gradually titrated based on efficacy and tolerability. Doses higher than 9 g per night have not been studied and should not ordinarily be administered.

2.2Pediatric Dosing Information The recommended starting pediatric dosage, titration regimen, and maximum total nightly dosage are based on patient weight. Pediatric Patients 7 years and Older Weighing at least 45 kg The recommended starting dosage of LUMRYZ in pediatric patients 7 years and older weighing at least 45 kg is 4.5 g once per night administered orally. Increase the dosage by 1.5 g per night at weekly intervals to the maximum recommended dosage of 9 g once per night orally.

The dosage may be gradually titrated based on efficacy and tolerability. Pediatric Patients 7 years and Older Weighing Less than 45 kg Because the recommended starting dosage in pediatric patients 7 years and older weighing less than 45 kg cannot be achieved with the available strengths of LUMRYZ, use another sodium oxybate product to initiate treatment. Refer to the Prescribing Information of other sodium oxybate products for the recommended dosage for those products.

The maximum recommended dosage for patients 7 years and older weighing 20 kg to <30 kg is 6 g once per night orally, and the maximum recommended dosage for patients 7 years and older weighing 30 kg to <45 kg is 7.5 g once per night orally [ see Dosage and Administration ( 2.4 ) ]. There is insufficient information to provide specific dosing recommendations for patients 7 years and older who weigh less than 20 kg.

2.3Important Administration Instructions LUMRYZ is taken orally as a single dose at bedtime. Prepare the dose of LUMRYZ prior to bedtime. Prior to ingestion, the dose of LUMRYZ should be suspended in approximately 1/3 cup (approximately 80 mL) of water (with or without calorie-free drink mix or flavored water enhancer) in the mixing cup provided [see Instructions for Use ] .

Do not use hot water [see Clinical Pharmacology (12.3) ] . After mixing, consume LUMRYZ within 30 minutes. Take LUMRYZ at least 2 hours after eating [see Clinical Pharmacology (12.3) ].

Patients should take LUMRYZ while in bed and lie down immediately after dosing as LUMRYZ may cause them to fall asleep abruptly without first feeling drowsy. Patients will often fall asleep within 5 minutes of taking LUMRYZ, and will usually fall asleep within 15 minutes, though t…

💊 Dosage Forms and Strengths 50 words ▾

3 DOSAGE FORMS AND STRENGTHS For extended-release oral suspension: LUMRYZ is a white to off-white powder provided in packets of 4.5 g, 6 g, 7.5 g, or 9 g of sodium oxybate. For extended-release oral suspension: Packets of 4.5 g, 6 g, 7.5 g, or 9 g ( 3 )

⛔ Contraindications 60 words ▾

4 CONTRAINDICATIONS LUMRYZ is contraindicated for use in: ● combination with sedative hypnotics [see Warnings and Precautions (5.1) ] ● combination with alcohol [see Warnings and Precautions (5.1) ] ● patients with succinic semialdehyde dehydrogenase deficiency [see Clinical Pharmacology (12.3) ] • In combination with sedative hypnotics or alcohol ( 4 ). • Succinic semialdehyde dehydrogenase deficiency ( 4 ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • CNS depression: Use caution when considering the concurrent use of LUMRYZ with other CNS depressants ( 5.1 ). • Caution patients against hazardous activities requiring complete mental alertness or motor coordination within the first 6 hours of dosing or after first initiating treatment until certain that LUMRYZ does not affect them adversely ( 5.1 ). • Depression and suicidality: Monitor patients for emergent or increased depression and suicidality ( 5.5 ). • Confusion/Anxiety: Monitor for impaired motor/cognitive function ( 5.6 ). • Parasomnias: Evaluate episodes of sleepwalking ( 5.7 ). • High sodium content in LUMRYZ: Monitor patients with heart failure, hypertension, or impaired renal function ( 5.8 ).

5.1Central Nervous System Depression LUMRYZ is a central nervous system (CNS) depressant. Clinically significant respiratory depression and obtundation has occurred in patients treated with immediate-release sodium oxybate at recommended doses in clinical trials and may occur in patients treated with LUMRYZ at recommended doses. LUMRYZ is contraindicated in combination with alcohol and sedative hypnotics.

The concurrent use of LUMRYZ with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating antiepileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death. If use of these CNS depressants in combination with LUMRYZ is required, dose reduction or discontinuation of one or more CNS depressants (including LUMRYZ) should be considered.

In addition, if short-term use of an opioid (e.g., post- or perioperative) is required, interruption of treatment with LUMRYZ should be considered. In addition to coadministration of LUMRYZ and alcohol being contraindicated because of respiratory depression, consumption of alcohol while taking LUMRYZ may also result in a more rapid release of the dose of sodium oxybate [see Clinical Pharmacology (12.3) ] . Healthcare providers should caution patients about operating hazardous machinery, including automobiles or airplanes, until they are reasonably certain that LUMRYZ does not affect them adversely (e.g., impair judgment, thinking, or motor skills).

Patients should not engage in hazardous occupations or activities requiring complete mental alertness or motor coordination, such as operating machinery or a motor vehicle or flying an airplane, for at least 6 hours after taking LUMRYZ. Patients should be queried about CNS depression-related events upon initiation of LUMRYZ therapy and periodically thereafter. LUMRYZ is available only through a restricted program under a REMS [see Warnings and Precautions (5.3) ].

5.2Abuse and Misuse LUMRYZ is a Schedule III controlled substance. The active ingredient of LUMRYZ, sodium oxybate, is the sodium salt of gamma-hydroxybutyrate (GHB), a Schedule I controlled substance. Abuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death.

The rapid onset of sedation, coupled with the amnestic features of GHB, particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (e.g., assault victim). Because illicit use and abuse of GHB have been reported, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of GHB (e.g., increase in size or frequency of dosing, drug-seeking behavior, feigned cataplexy) [see Warnings and Precautions (5.3) and Drug Abuse and Dependence (9.2) ].

LUMRYZ is available only through a restricted program under a REMS [see Warnings and Precautions (5.3) ].

5.3 LUMRYZ REMS LUMRYZ is available only through a restr…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions appear in other sections of the labeling: ● CNS Depression [see Warnings and Precautions (5.1) ] ● Abuse and Misuse [see Warnings and Precautions (5.2) ] ● Respiratory Depression and Sleep-Disordered Breathing [see Warnings and Precautions (5.4) ] ● Depression and Suicidality [see Warnings and Precautions (5.5) ] ● Other Behavioral or Psychiatric Adverse Reactions [see Warnings and Precautions (5.6) ] ● Parasomnias [see Warnings and Precautions (5.7) ] ● Use in Patients Sensitive to High Sodium Intake [see Warnings and Precautions (5.8) ] Most common adverse reactions in adults (incidence ≥ 5% and greater than placebo) reported for any dose of LUMRYZ were nausea, dizziness, enuresis, headache, and vomiting ( 6.1 ).

Most common adverse reactions for pediatric patients (≥ 5%) in a study with immediate-release sodium oxybate were nausea, enuresis, vomiting, headache, weight decreased, decreased appetite, dizziness, and sleepwalking ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Avadel CNS Pharmaceuticals, LLC at 1-888-828-2335 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. Adult Patients LUMRYZ was studied in one placebo-controlled trial (Study 1) [see Clinical Studies (14.1) ] in 212 patients with narcolepsy (107 patients treated with LUMRYZ and 105 with placebo). Adverse Reactions Leading to Treatment Discontinuation In Study 1, 15.9% of patients treated with LUMRYZ discontinued because of adverse reactions, compared to 1.9% of patients receiving placebo.

The most common adverse reaction leading to discontinuation was dizziness (4.7%). For LUMRYZ, 5.6% of patients discontinued due to adverse reactions on 4.5 g, 4.1% on 6 g, 4.5% on 7.5 g, and 3.9% on 9 g dose. Most Common Adverse Reactions The most common adverse reactions (incidence ≥5% and greater than placebo) reported for any dose of LUMRYZ were nausea, dizziness, enuresis, headache, and vomiting.

Adverse Reactions Occurring at an Incidence of 2% or Greater Table 2 lists adverse reactions occurring in 2% or more of LUMRYZ-treated patients on any individual dose and at a rate greater than placebo-treated patients in Study 1. Table 2: Adverse Reactions Occurring in 2% or More of LUMRYZ-Treated Adult Patients and Greater than for Placebo-Treated Patients in Study 1 Adverse Reaction Placebo (N=105) % LUMRYZ 4.5 g (N=107) % LUMRYZ 6 g (N=97) % LUMRYZ 7.5 g (N=88) % LUMRYZ 9 g (N=77) % Gastrointestinal Disorders Vomiting 2 3 3 6 5 Nausea 3 6 8 7 1 Investigations Weight Decreased 0 1 0 0 4 Metabolism and Nutritional Disorders Decreased Appetite 0 4 4 3 3 Nervous System Disorders Dizziness 0 6 4 6 5 Somnolence 1 0 1 2 4 Headache 6 7 5 6 0 Psychiatric Disorders Enuresis 0 2 4 9 9 Anxiety 1 3 1 3 1 Somnambulism 0 1 2 0 0 Dose-Response Information In the clinical trial in adult patients with narcolepsy, a dose-response relationship was observed for enuresis and somnolence.

Additional Adverse Reactions Adverse reactions observed in clinical studies with immediate-release sodium oxybate (≥2%), but not observed in Study 1 at a frequency of higher than 2%, and which may be relevant for LUMRYZ: diarrhea, abdominal pain upper, dry mouth, pain, feeling drunk, peripheral edema, cataplexy, muscle spasms, pain in extremity, tremor, disturbance in attention, paresthesia, sleep paralysis, disorientation, irritability, and hyperhidrosis. Pediatric Patients (7 Years of Age and Older) The safety of LUMRYZ for the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years of age and older with narcolepsy is supported by an adequate and well-controlled trial of immediate-release sodium oxyba…

🔄 Drug Interactions 81 words ▾

7 DRUG INTERACTIONS

7.1Alcohol, Sedative Hypnotics, and CNS Depressants LUMRYZ is contraindicated for use in combination with alcohol or sedative hypnotics. Use of other CNS depressants may potentiate the CNS-depressant effects of LUMRYZ [see Warnings and Precautions (5.1) ] . In addition to coadministration of LUMRYZ and alcohol being contraindicated because of respiratory depression, consumption of alcohol while taking LUMRYZ may also result in a more rapid release of the dose of sodium oxybate [see Clinical Pharmacology (12.3) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: Based on animal data, may cause fetal harm ( 8.1 ). • Geriatric patients: Monitor for impaired motor and/or cognitive function when taking LUMRYZ ( 8.5 ). • Hepatic Impairment: Because of an increase in exposure, LUMRYZ should not be initiated in patients with hepatic impairment because appropriate dosage adjustments for initiation of LUMRYZ cannot be made ( 8.6 ).

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of sodium oxybate in pregnant women. Oral administration of sodium oxybate to pregnant rats (150, 350, or 1,000 mg/kg/day) or rabbits (300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity; however, oral administration to rats throughout pregnancy and lactation resulted in increased stillbirths and decreased offspring postnatal viability and growth, at a clinically relevant dose [see Data] .

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. The background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations Labor or Delivery LUMRYZ has not been studied in labor or delivery.

In obstetric anesthesia using an injectable formulation of sodium oxybate, newborns had stable cardiovascular and respiratory measures but were very sleepy, causing a slight decrease in Apgar scores. There was a fall in the rate of uterine contractions 20 minutes after injection. Placental transfer is rapid and gamma-hydroxybutyrate (GHB) has been detected in newborns at delivery after intravenous administration of GHB to mothers.

Subsequent effects of sodium oxybate on later growth, development, and maturation in humans are unknown. Data Animal Data Oral administration of sodium oxybate to pregnant rats (150, 350, or 1,000 mg/kg/day) or rabbits (300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity. The highest doses tested in rats and rabbits were approximately 1 and 3 times, respectively, the maximum recommended human dose (MRHD) of 9 g per night on a body surface area (mg/m 2 ) basis.

Oral administration of sodium oxybate (150, 350, or 1,000 mg/kg/day) to rats throughout pregnancy and lactation resulted in increased stillbirths and decreased offspring postnatal viability and body weight gain at the highest dose tested. The no-effect dose for pre- and postnatal developmental toxicity in rats is less than the MRHD on a mg/m 2 basis.

8.2Lactation Risk Summary GHB is excreted in human milk after oral administration of sodium oxybate. There is insufficient information on the risk to a breastfed infant, and there is insufficient information on milk production in nursing mothers. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LUMRYZ and any potential adverse effects on the breastfed infant from LUMRYZ or from the underlying maternal condition.

8.4Pediatric Use LUMRYZ has not been studied in a pediatric clinical trial. The safety and effectiveness of LUMRYZ in the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years of age and older with narcolepsy is supported by evidence from a double-blind, placebo-controlled, randomized-withdrawal study of immediate-release sodium oxybate [see Adverse Reactions (6.1) and Clinical Studies (14.2) ]. In the pediatric clinical trial with immediate-release sodium oxybate administration in pediatric patients 7 years of age and older with narcolepsy, serious adverse reactions of central sleep apnea and oxygen desaturation documented by polysomnography evaluation; depression; suicidal ideation; neuropsychiatric reactions including acute psychosis, confusion, and anxiety; and parasomnias, including sleepwalking, have been reported [see Wa…

🆘 Overdosage ~2 min read ▾

10 OVERDOSAGE

10.1Human Experience Information regarding overdose with LUMRYZ is derived largely from reports in the medical literature that describe symptoms and signs in individuals who have ingested GHB illicitly. In these circumstances, the co-ingestion of other drugs and alcohol was common and may have influenced the presentation and severity of clinical manifestations of overdose. In adult clinical trials of immediate-release sodium oxybate, two cases of overdose with sodium oxybate were reported.

In the first case, an estimated dose of 150 g, more than 15 times the maximum recommended dose, caused a patient to be unresponsive with brief periods of apnea and to be incontinent of urine and feces. This individual recovered without sequelae. In the second case, death was reported following a multiple drug overdose consisting of sodium oxybate and numerous other drugs.

10.2Signs and Symptoms Information about signs and symptoms associated with overdosage with LUMRYZ derives from reports of illicit use of GHB. Patient presentation following overdose is influenced by the dose ingested, the time since ingestion, the co-ingestion of other drugs and alcohol, and the fed or fasted state. Patients have exhibited varying degrees of depressed consciousness that may fluctuate rapidly between a confusional, agitated combative state with ataxia and coma.

Emesis (even when obtunded), diaphoresis, headache, and impaired psychomotor skills have been observed. No typical pupillary changes have been described to assist in diagnosis; pupillary reactivity to light is maintained. Blurred vision has been reported.

An increasing depth of coma and acidosis have been observed at higher doses. Myoclonus and tonic-clonic seizures have been reported. Respiration may be unaffected or compromised in rate and depth.

Cheyne-Stokes respiration and apnea have been observed. Bradycardia and hypothermia may accompany unconsciousness, as well as muscular hypotonia, but tendon reflexes remain intact.

10.3Recommended Treatment of Overdose General symptomatic and supportive care should be instituted immediately, and gastric decontamination may be considered if co-ingestants are suspected. Because emesis may occur in the presence of obtundation, appropriate posture (left lateral recumbent position) and protection of the airway by intubation may be warranted. Although the gag reflex may be absent in deeply comatose patients, even unconscious patients may become combative to intubation, and rapid-sequence induction (without the use of sedative) should be considered.

Vital signs and consciousness should be closely monitored. The bradycardia reported with GHB overdose has been responsive to atropine intravenous administration. No reversal of the central depressant effects of LUMRYZ can be expected from naloxone or flumazenil administration.

The use of hemodialysis and other forms of extracorporeal drug removal have not been studied in GHB overdose, but have been reported in cases of acidosis associated with GHB ingestions of 125 g or greater; however, due to the rapid metabolism of sodium oxybate, these measures may not be warranted.

10.4Poison Control Center As with the management of all cases of drug overdosage, the possibility of multiple drug ingestion should be considered. The healthcare provider is encouraged to collect urine and blood samples for routine toxicologic screening, and to consult with a regional poison control center (1-800-222-1222) for current treatment recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action LUMRYZ is a CNS depressant. The mechanism of action of LUMRYZ in the treatment of narcolepsy is unknown. Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB), an endogenous compound and metabolite of the neurotransmitter GABA.

It is hypothesized that the therapeutic effects of LUMRYZ on cataplexy and excessive daytime sleepiness are mediated through GABA B actions at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons.

12.3Pharmacokinetics Following oral administration of LUMRYZ, the plasma levels of GHB increased dose-proportionally for C max and more than dose-proportionally for area under the plasma concentration-time curve (AUC inf ) (respectively, 2-fold and 2.3-fold increases as total daily dose is doubled from 4.5 g to 9 g). No clinically significant difference in oxybate pharmacokinetics was observed between a single 6 g dose of LUMRYZ and two 3 g doses of immediate-release sodium oxybate administered 4 hours apart. Absorption Following oral administration of a single 6 g dose of LUMRYZ, the peak plasma concentration (C max ) was 66 mcg/mL and the time to peak plasma concentration (T max ) was 1.5 hours.

Effect of Food Administration of LUMRYZ immediately after a high-fat meal resulted in a mean reduction in C max and AUC of GHB by 33% and 14%, respectively; average T max increased from 0.5 hours to 1.5 hours [ see Dosage and Administration (2.3) ]. Effect of Ethanol An in vitro study showed alcohol-induced dose-dumping of sodium oxybate from extended-release oral suspension at 1 hour in the presence of 40% alcohol, and approximately 60% increase of drug release at 2 hours in the presence of 20% alcohol [see Contraindications (4) and Warnings and Precautions (5.1) ] .

Effect of Water Temperature An in vitro dissolution study showed that LUMRYZ mixed with hot water (90°C) resulted in a dose-dumping phenomenon for the release of sodium oxybate, whereas warm water (50°C) did not significantly affect the drug release from the extended-release suspension [ see Dosage and Administration (2.3) ]. Effect of Water Flavoring An in vitro dissolution study showed that LUMRYZ mixed with water prepared with calorie-free drink mix (e.g., Crystal Light Raspberry Lemonade Drink Mix) or flavored water enhancer (e.g., Mio Fruit Punch Concentrate Liquid Water Enhancer) did not impact the drug release from the extended-release suspension [see Dosage and Administration (2.3) ].

Distribution GHB is a hydrophilic compound with an apparent volume of distribution averaging 190 mL/kg to 384 mL/kg. At GHB concentrations ranging from 3 mcg/mL to 300 mcg/mL, less than 1% is bound to plasma proteins. Elimination Metabolism Animal studies indicate that metabolism is the major elimination pathway for GHB, producing carbon dioxide and water via the tricarboxylic acid (Krebs) cycle, and secondarily by β-oxidation.

The primary pathway involves a cytosolic NADP + -linked enzyme, GHB dehydrogenase, which catalyzes the conversion of GHB to succinic semialdehyde, which is then biotransformed to succinic acid by the enzyme succinic semialdehyde dehydrogenase. Succinic acid enters the Krebs cycle where it is metabolized to carbon dioxide and water. A second mitochondrial oxidoreductase enzyme, a transhydrogenase, also catalyzes the conversion to succinic semialdehyde in the presence of α-ketoglutarate.

An alternate pathway of biotransformation involves β-oxidation via 3,4-dihydroxybutyrate to carbon dioxide and water. No active metabolites have been identified. Excretion The clearance of GHB is almost entirely by biotransformation to carbon dioxide, which is then eliminated by expiration.

On average, less than 5% of unchanged drug appears in human urine within 6 to 8 hours after dosing. Fecal excretion is negligible. GHB has an elimination half-life of 0.5 to 1 hour.

Specific Population Geriatric Patients There is limited experience with LUMRYZ in the elderly. Results from…

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied LUMRYZ is a blend of white to off-white granules for extended-release oral suspension in water. LUMRYZ is supplied in cartons and a 28-day starter pack. Cartons : each carton contains either 7 or 30 packets of LUMRYZ, a mixing cup, Prescribing Information and Medication Guide, and Instructions for Use (see Table 8).

Dose packets contain a single dose of LUMRYZ provided in 4.5 g, 6 g, 7.5 g, or 9 g doses. Table 8: LUMRYZ Carton Configurations Strength Package Size NDC Number 4.5 g 7 packets NDC 13551-001-07 30 packets NDC 13551-001-30 6 g 7 packets NDC 13551-002-07 30 packets NDC 13551-002-30 7.5 g 7 packets NDC 13551-003-07 30 packets NDC 13551-003-30 9 g 7 packets NDC 13551-004-07 30 packets NDC 13551-004-30 28-day Starter Pack : contains four 7-count cartons, each containing a mixing cup, Prescribing Information and Medication Guide, and Instructions for Use (see Table 9).

Dose packets contain a single dose of LUMRYZ provided in 4.5 g, 6 g, or 7.5 g doses. Table 9: LUMRYZ Starter Pack Contents 28-day Starter Pack Strength Package Size NDC Number Week 1 4.5 g 7 packets NDC 13551-005-01 Week 2 6 g 7 packets Week 3 6 g 7 packets Week 4 7.5 g 7 packets

16.2Storage Keep out of reach of children. LUMRYZ should be stored 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). Suspensions should be consumed within 30 minutes.

16.3Handling and Disposal LUMRYZ is a Schedule III drug under the Controlled Substances Act. LUMRYZ should be handled according to state and federal regulations. It is safe to dispose of LUMRYZ down the sanitary sewer.

📋 Description 113 words ▾

11 DESCRIPTION Sodium oxybate, a CNS depressant, is the active ingredient in LUMRYZ for extended-release oral suspension. The chemical name for sodium oxybate is sodium 4-hydroxybutyrate. The molecular formula is C 4 H 7 NaO 3 , and the molecular weight is 126.09 g/mole.

The chemical structure is: Sodium oxybate is a white to off-white solid powder. Each packet of LUMRYZ contains 4.5 g, 6 g, 7.5 g, or 9 g of sodium oxybate, equivalent to 3.7 g, 5.0 g, 6.2 g, or 7.4 g of oxybate, respectively. The inactive ingredients are carrageenan, hydrogenated vegetable oil, hydroxyethyl cellulose, magnesium stearate, malic acid, methacrylic acid copolymer, microcrystalline cellulose, povidone, and xanthan gum. image description

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Central Nervous System Depression Inform patients and/or caregivers that LUMRYZ can cause central nervous system depression, including respiratory depression, hypotension, profound sedation, syncope, and death. Instruct patients to not engage in activities requiring mental alertness or motor coordination, including operating hazardous machinery, for at least 6 hours after taking LUMRYZ.

Instruct patients and/or caregivers to inform their healthcare providers of all the medications they take [see Warnings and Precautions (5.1) ]. Abuse and Misuse Inform patients and/or caregivers that the active ingredient of LUMRYZ is gamma-hydroxybutyrate (GHB), which is associated with serious adverse reactions with illicit use and abuse [see Warnings and Precautions (5.2) ]. LUMRYZ REMS LUMRYZ is available only through a restricted program called the LUMRYZ REMS [see Warnings and Precautions (5.3) ] .

Inform the patient and/or caregiver of the following notable requirements: ● LUMRYZ is dispensed only by pharmacies that are specially certified ● LUMRYZ will be dispensed and shipped only to patients who are enrolled in the LUMRYZ REMS LUMRYZ is available only from certified pharmacies participating in the program. Therefore, provide patients and/or caregivers with the telephone number and website for information on how to obtain the product. Alcohol or Sedative Hypnotics Advise patients and/or caregivers that alcohol and other sedative hypnotics should not be taken with LUMRYZ [see Contraindications (4) and Warnings and Precautions (5.1) ] .

Sedation Inform patients and/or caregivers that they are likely to fall asleep quickly after taking LUMRYZ (often within 5 and usually within 15 minutes), but the time it takes to fall asleep can vary from night to night. The sudden onset of sleep, including in a standing position or while rising from bed, has led to falls complicated by injuries, in some cases requiring hospitalization [see Adverse Reactions (6.2) ] . Instruct patients and/or caregivers that they should remain in bed following ingestion of their dose [see Dosage and Administration (2.3) ] .

Food Effects on LUMRYZ Inform patients and/or caregivers that LUMRYZ should be taken at least 2 hours after eating. Respiratory Depression and Sleep-Disordered Breathing Inform patients and/or caregivers that LUMRYZ may impair respiratory drive, especially in patients with compromised respiratory function, and may cause apnea [see Warnings and Precautions (5.4) ]. Depression and Suicidality Instruct patients and/or caregivers to contact a healthcare provider immediately if they develop depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or suicidal ideation [see Warnings and Precautions (5.5) ].

Other Behavioral or Psychiatric Adverse Reactions Inform patients and/or caregivers that LUMRYZ can cause behavioral or psychiatric adverse reactions, including confusion, anxiety, and psychosis. Instruct them to notify their healthcare provider if any of these types of symptoms occur [see Warnings and Precautions (5.6) ]. Sleepwalking Instruct patients and/or caregivers that LUMRYZ has been associated with sleepwalking and other behaviors during sleep, and to contact their healthcare provider if this occurs [see Warnings and Precautions (5.7) ].

Sodium Intake Instruct patients and/or caregivers that LUMRYZ contains a significant amount of sodium and patients who are sensitive to sodium intake (e.g., those with heart failure, hypertension, or renal impairment) should limit their sodium intake [see Warnings and Precautions (5.8) ]. Distributed By: Avadel CNS Pharmaceuticals, LLC Chesterfield, MO Prot…

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 10/2024 Medication Guide LUMRYZ TM (LOOM rize) (sodium oxybate) for extended-release oral suspension, CIII Read this Medication Guide carefully before you start taking LUMRYZ and each time you get a refill.

There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment. What is the most important information I should know about LUMRYZ? ● LUMRYZ is a central nervous system (CNS) depressant.

Taking LUMRYZ with other CNS depressants such as medicines used to make you fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs, may cause serious medical problems, including: ○ trouble breathing (respiratory depression) ○ low blood pressure (hypotension) ○ changes in alertness (drowsiness) ○ fainting (syncope) ○ death Ask your doctor if you are not sure if you are taking a medicine listed above. ● LUMRYZ is a federal controlled substance (CIII).

The active ingredient of LUMRYZ is a form of gamma-hydroxybutyrate (GHB) that is also a federal controlled substance (CI). Abuse of illegal GHB, either alone or with other CNS depressants may cause serious medical problems, including: ○ seizure ○ trouble breathing (respiratory depression) ○ changes in alertness (drowsiness) ○ coma ○ death Call your doctor right away if you have any of these serious side effects. ● Anyone who takes LUMRYZ should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery, or flying an airplane, for at least 6 hours after taking LUMRYZ.

Those activities should not be done until you know how LUMRYZ affects you. ● Keep LUMRYZ in a safe place to prevent abuse and misuse. Selling or giving away LUMRYZ may harm others and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. ● Because of the risk of CNS depression, abuse, and misuse, LUMRYZ is available only by prescription and filled through certified pharmacies in the LUMRYZ REMS.

You must be enrolled in the LUMRYZ REMS to receive LUMRYZ. For more information on how to receive LUMRYZ, visit www.LUMRYZREMS.com . Before you receive LUMRYZ, your doctor or pharmacist will make sure that you understand how to use LUMRYZ safely and effectively.

If you have any questions about LUMRYZ, ask your doctor or call the LUMRYZ REMS at 1-877-453-1029. What is LUMRYZ? LUMRYZ is a prescription medicine used in people 7 years of age or older to treat the following symptoms of narcolepsy: ● sudden onset of weak or paralyzed muscles (cataplexy), or ● excessive daytime sleepiness (EDS) It is not known if LUMRYZ is safe and effective in children under 7 years of age.

Do not take LUMRYZ if you or your child: ● take other sleep medicines or sedatives (medicines that cause sleepiness) ● drink alcohol ● have a rare problem called succinic semialdehyde dehydrogenase deficiency Before taking LUMRYZ, tell your doctor about all medical conditions, including if you or your child: ● have a history of drug abuse. ● have short periods of not breathing while sleeping (sleep apnea). ● have trouble breathing or have lung problems. You or your child may have a higher chance of having serious breathing problems when taking LUMRYZ. ● have or had depression or have tried to harm yourself.

You or your child should be watched carefully for new symptoms of depression. ● have or had behavior or other psychiatric problems such as: ○ anxiety ○ seeing or hearing things that are not real (hallucinations) ○ feeling more suspicious (paranoia) ○ being out of touch with reality (psychosis) ○ acting aggressive ○ agitation ● have liver problems. ● are on a salt-restricted diet. LUMRYZ contains a lot of sodium (salt) and may not be rig…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 13551-0003-07 · Avadel 13551-0005-01 · Avadel →
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.