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Lumryz

sodium oxybate · For Suspension, Extended Release

Prescription NDA Schedule CIII RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Lumryz
Generic name
sodium oxybate
Dosage form
For Suspension, Extended Release
Route
Oral
Marketing category
NDA · NDA
Labeler
Alkermes, Inc.
Product type
Human Prescription Drug
DEA schedule
CIII
Active ingredients
4
NDC product codes
4
Packages
8
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Sodium Oxybate 4.5 g/1 349482 View
Sodium Oxybate 6 g/1 349482 View
Sodium Oxybate 7.5 g/1 349482 View
Sodium Oxybate 9 g/1 349482 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
For Suspension, Extended Release
Route of administration
Oral
Presentations
12

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Central Nervous System Depressant [EPC] EPC 2 members — no class page
Central Nervous System Depression [PE] PE All 14 members
Decreased Central Nervous System Organized Electrical Activity [PE] PE 2 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
214755
Application type
NDA · New Drug Application
Approval date
May 1, 2023
Sponsor
ALKERMES INC
Products on application
4
Submissions recorded
6
Products approved under application 214755.
Product Trade name Form Strength Ingredient Status TE Flags
214755-001 LUMRYZ FOR SUSPENSION, EXTENDED RELEASE SODIUM OXYBATE Prescription — RLD RS
214755-002 LUMRYZ FOR SUSPENSION, EXTENDED RELEASE SODIUM OXYBATE Prescription — RLD
214755-003 LUMRYZ FOR SUSPENSION, EXTENDED RELEASE SODIUM OXYBATE Prescription — RLD
214755-004 LUMRYZ FOR SUSPENSION, EXTENDED RELEASE SODIUM OXYBATE Prescription — RLD

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
12303478 July 21, 2037 001 No U-4189 June 2, 2025
11602513 July 21, 2037 001 No U-3576 May 23, 2023
11602512 July 21, 2037 001 No U-3577 May 23, 2023
11400065 July 21, 2037 001 No U-3579 May 23, 2023
11000498 July 21, 2037 001 No U-3580 May 23, 2023
12128021 July 21, 2037 001 No U-4022 November 12, 2024
11986451 July 21, 2037 001 No U-3934 May 29, 2024
10952986 July 21, 2037 001 No U-3601 May 23, 2023
12097176 July 21, 2037 001 No U-4006 October 15, 2024
11896572 July 21, 2037 001 No February 20, 2024
10272062 July 21, 2037 001 No May 23, 2023
11504347 July 21, 2037 001 No May 23, 2023
12109186 July 21, 2037 001 No October 15, 2024
11839597 July 21, 2037 001 No January 4, 2024
12097175 July 21, 2037 001 No October 15, 2024
12115144 July 21, 2037 001 No October 22, 2024
12144793 July 21, 2037 001 No November 22, 2024
11052061 July 21, 2037 001 No May 23, 2023
12115143 July 21, 2037 001 No October 22, 2024
12115142 July 21, 2037 001 No October 22, 2024
11065224 July 21, 2037 001 No May 23, 2023
12138239 July 21, 2037 001 No November 15, 2024
10973795 July 21, 2037 001 No May 23, 2023
11766418 July 21, 2037 001 No September 29, 2023
12115145 July 21, 2037 001 No October 22, 2024
10736866 July 21, 2037 001 No May 23, 2023
12303478 July 21, 2037 002 No U-4189 June 2, 2025
11602513 July 21, 2037 002 No U-3576 May 23, 2023
11602512 July 21, 2037 002 No U-3577 May 23, 2023
11400065 July 21, 2037 002 No U-3579 May 23, 2023
11000498 July 21, 2037 002 No U-3580 May 23, 2023
12128021 July 21, 2037 002 No U-4022 November 12, 2024
11986451 July 21, 2037 002 No U-3934 May 29, 2024
10952986 July 21, 2037 002 No U-3601 May 23, 2023
11826335 July 21, 2037 002 No U-3751 December 4, 2023
12097176 July 21, 2037 002 No U-4006 October 15, 2024
11065224 July 21, 2037 002 No May 23, 2023
12115143 July 21, 2037 002 No October 22, 2024
12138239 July 21, 2037 002 No November 15, 2024
10973795 July 21, 2037 002 No May 23, 2023
12115142 July 21, 2037 002 No October 22, 2024
12115144 July 21, 2037 002 No October 22, 2024
12115145 July 21, 2037 002 No October 22, 2024
11766418 July 21, 2037 002 No September 29, 2023
12097175 July 21, 2037 002 No October 15, 2024
11504347 July 21, 2037 002 No May 23, 2023
10736866 July 21, 2037 002 No May 23, 2023
11839597 July 21, 2037 002 No January 4, 2024
12144793 July 21, 2037 002 No November 22, 2024
11896572 July 21, 2037 002 No February 20, 2024
12109186 July 21, 2037 002 No October 15, 2024
11052061 July 21, 2037 002 No May 23, 2023
10272062 July 21, 2037 002 No May 23, 2023
12303478 July 21, 2037 003 No U-4189 June 2, 2025
11602513 July 21, 2037 003 No U-3576 May 23, 2023
11602512 July 21, 2037 003 No U-3577 May 23, 2023
11400065 July 21, 2037 003 No U-3579 May 23, 2023
11000498 July 21, 2037 003 No U-3580 May 23, 2023
12128021 July 21, 2037 003 No U-4022 November 12, 2024
11986451 July 21, 2037 003 No U-3934 May 29, 2024
10952986 July 21, 2037 003 No U-3601 May 23, 2023
12097176 July 21, 2037 003 No U-4006 October 15, 2024
12109186 July 21, 2037 003 No October 15, 2024
12115143 July 21, 2037 003 No October 22, 2024
11896572 July 21, 2037 003 No February 20, 2024
10272062 July 21, 2037 003 No May 23, 2023
12115142 July 21, 2037 003 No October 22, 2024
11839597 July 21, 2037 003 No January 4, 2024
12138239 July 21, 2037 003 No November 15, 2024
11504347 July 21, 2037 003 No May 23, 2023
12115145 July 21, 2037 003 No October 22, 2024
12097175 July 21, 2037 003 No October 15, 2024
10973795 July 21, 2037 003 No May 23, 2023
11065224 July 21, 2037 003 No May 23, 2023
11052061 July 21, 2037 003 No May 23, 2023
12115144 July 21, 2037 003 No October 22, 2024
11766418 July 21, 2037 003 No September 29, 2023
10736866 July 21, 2037 003 No May 23, 2023
12144793 July 21, 2037 003 No November 22, 2024
12303478 July 21, 2037 004 No U-4189 June 2, 2025
11602512 July 21, 2037 004 No U-3577 May 23, 2023
11400065 July 21, 2037 004 No U-3579 May 23, 2023
11000498 July 21, 2037 004 No U-3580 May 23, 2023
12128021 July 21, 2037 004 No U-4022 November 12, 2024
11986451 July 21, 2037 004 No U-3934 May 29, 2024
10952986 July 21, 2037 004 No U-3601 May 23, 2023
11602513 July 21, 2037 004 No U-3576 May 23, 2023
12097176 July 21, 2037 004 No U-4006 October 15, 2024
11896572 July 21, 2037 004 No February 20, 2024
11839597 July 21, 2037 004 No January 4, 2024
11766418 July 21, 2037 004 No September 29, 2023
12115144 July 21, 2037 004 No October 22, 2024
12115142 July 21, 2037 004 No October 22, 2024
10973795 July 21, 2037 004 No May 23, 2023
12115143 July 21, 2037 004 No October 22, 2024
12097175 July 21, 2037 004 No October 15, 2024
12138239 July 21, 2037 004 No November 15, 2024
12144793 July 21, 2037 004 No November 22, 2024
10272062 July 21, 2037 004 No May 23, 2023
10736866 July 21, 2037 004 No May 23, 2023
11065224 July 21, 2037 004 No May 23, 2023
11052061 July 21, 2037 004 No May 23, 2023
12115145 July 21, 2037 004 No October 22, 2024
12109186 July 21, 2037 004 No October 15, 2024
11504347 July 21, 2037 004 No May 23, 2023
11583510 February 7, 2042 001 No U-3578 May 23, 2023
11583510 February 7, 2042 002 No U-3578 May 23, 2023
11583510 February 7, 2042 003 No U-3578 May 23, 2023
11583510 February 7, 2042 004 No U-3578 May 23, 2023
11779557 March 16, 2042 001 No U-3705 October 24, 2023
11779557 March 16, 2042 002 No U-3705 October 24, 2023
11779557 March 16, 2042 003 No U-3705 October 24, 2023
11779557 March 16, 2042 004 No U-3705 October 24, 2023
Regulatory exclusivity periods.
Code Expires Product
NP May 1, 2026 001
NP May 1, 2026 002
NP May 1, 2026 003
NP May 1, 2026 004
ODE-431 May 1, 2030 001
ODE-431 May 1, 2030 002
ODE-431 May 1, 2030 003
ODE-431 May 1, 2030 004
ODE-494 October 16, 2031 001
ODE-494 October 16, 2031 002
ODE-494 October 16, 2031 003
ODE-494 October 16, 2031 004

Approval history

Source: Drugs@FDA
Most recent submissions on application 214755.
Type No. Action Status Date Review
Supplement 12 REMS Approved March 10, 2025 N/A
Supplement 11 REMS Approved December 18, 2024 N/A
Supplement 6 Efficacy Approved October 16, 2024 Standard
Supplement 7 Labeling Approved September 26, 2024 Standard
Supplement 3 REMS Approved October 31, 2023 N/A
Original application 1 Type 3 - New Dosage Form Approved May 1, 2023 Standard

Review documents

  • 0 · Supplement · November 19, 2025
  • 0 · Supplement · March 12, 2025
  • 0 · Supplement · December 20, 2024
  • 0 · Supplement · December 4, 2024
  • 0 · Supplement · October 21, 2024
  • 0 · Supplement · October 21, 2024
  • 0 · Supplement · October 17, 2024
  • 0 · Supplement · September 27, 2024
  • 0 · Supplement · September 26, 2024
  • 0 · Supplement · January 11, 2024
  • 0 · Original application · November 7, 2023
  • 0 · Supplement · November 2, 2023
  • 0 · Original application · October 31, 2023
  • 0 · Original application · May 2, 2023
  • 0 · Original application · May 2, 2023

Adverse event reports

Source: openFDA FAERS
61,996
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: SODIUM OXYBATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
13551-001-07 13551-001 Alkermes, Inc. 7 PACKET in 1 CARTON (13551-001-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET May 1, 2023
13551-001-30 13551-001 Alkermes, Inc. 30 PACKET in 1 CARTON (13551-001-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET May 1, 2023
13551-002-07 13551-002 Alkermes, Inc. 7 PACKET in 1 CARTON (13551-002-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET May 1, 2023
13551-002-30 13551-002 Alkermes, Inc. 30 PACKET in 1 CARTON (13551-002-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET May 1, 2023
13551-003-07 13551-003 Alkermes, Inc. 7 PACKET in 1 CARTON (13551-003-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET May 1, 2023
13551-003-30 13551-003 Alkermes, Inc. 30 PACKET in 1 CARTON (13551-003-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET May 1, 2023
13551-004-07 13551-004 Alkermes, Inc. 7 PACKET in 1 CARTON (13551-004-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET May 1, 2023
13551-004-30 13551-004 Alkermes, Inc. 30 PACKET in 1 CARTON (13551-004-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET May 1, 2023
13551-001 13551-001 Alkermes, Inc. — May 1, 2023
13551-002 13551-002 Alkermes, Inc. — May 1, 2023
13551-003 13551-003 Alkermes, Inc. — May 1, 2023
13551-004 13551-004 Alkermes, Inc. — May 1, 2023

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.