Home NDC 0054-9628 sodium oxybate
Product NDC 0054-9628
11-digit product format 000549628
Labeler code 0054
Product ID 0054-9628_599719a1-b644-4ece-b0c0-ce8d85378e01
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sodium oxybate
Dosage form SOLUTION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA021196
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2023-01-03
Substance SODIUM OXYBATE
Active strength .5 g/mL
Pharmacologic classes Central Nervous System Depressant [EPC], Central Nervous System Depression [PE], Decreased Central Nervous System Organized Electrical Activity [PE]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021196-001 XYREM SODIUM OXYBATE 0.5GM/ML SOLUTION / ORAL AA RLD, RS 2002-07-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021196-001 AA
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021196-001 10213400 2033-03-15 U-2499 2019-03-28 N021196-001 10864181 2033-03-15 U-1532 2021-01-13 N021196-001 11253494 2033-03-15 U-3323 2022-03-15 N021196-001 11253494 2033-03-15 U-3324 2022-03-15 N021196-001 11986446 2033-03-15 U-3324 2024-06-18 N021196-001 8772306 2033-03-15 U-1532 2014-07-09 N021196-001 9050302 2033-03-15 U-1532 2015-07-08 N021196-001 9486426 2033-03-15 U-1532 2016-12-06 N021196-001 10213400*PED 2033-09-15 Pediatric extension N021196-001 10864181*PED 2033-09-15 Pediatric extension N021196-001 11253494*PED 2033-09-15 Pediatric extension N021196-001 8772306*PED 2033-09-15 Pediatric extension N021196-001 9050302*PED 2033-09-15 Pediatric extension N021196-001 9486426*PED 2033-09-15 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N021196-001 ODE-231 2025-10-26 N021196-001 PED 2026-04-26
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL AA RLD, RS 2002-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL AA RLD, RS 2002-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021196-001 XYREM 500MG/ML SOLUTION / ORAL AA RLD, RS 2002-07-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021196-001 XYREM 500MG/ML SOLUTION / ORAL AA RLD, RS 2002-07-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021196-001 XYREM 500MG/ML SOLUTION / ORAL AA RLD, RS 2002-07-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021196-001 XYREM 500MG/ML SOLUTION / ORAL AA RLD, RS 2002-07-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021196-001 XYREM 0.5GM/ML SOLUTION / ORAL RLD, RS 2002-07-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 18 · 693 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021196-001 10213400 2033-03-15 U-2499 2019-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021196-001 10864181 2033-03-15 U-1532 2021-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021196-001 11253494 2033-03-15 U-3323 2022-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021196-001 11253494 2033-03-15 U-3324 2022-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021196-001 11986446 2033-03-15 U-3324 2024-06-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021196-001 8772306 2033-03-15 U-1532 2014-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021196-001 9050302 2033-03-15 U-1532 2015-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021196-001 9486426 2033-03-15 U-1532 2016-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021196-001 10213400*PED 2033-09-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021196-001 10864181*PED 2033-09-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021196-001 11253494*PED 2033-09-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021196-001 8772306*PED 2033-09-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021196-001 9050302*PED 2033-09-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021196-001 9486426*PED 2033-09-15 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021196-001 10213400 2033-03-15 U-2499 2019-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021196-001 10864181 2033-03-15 U-1532 2021-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021196-001 11253494 2033-03-15 U-3323 2022-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021196-001 11253494 2033-03-15 U-3324 2022-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021196-001 11986446 2033-03-15 U-3324 2024-06-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021196-001 8772306 2033-03-15 U-1532 2014-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021196-001 9050302 2033-03-15 U-1532 2015-07-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021196-001 9486426 2033-03-15 U-1532 2016-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021196-001 10213400*PED 2033-09-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021196-001 10864181*PED 2033-09-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021196-001 11253494*PED 2033-09-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021196-001 8772306*PED 2033-09-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021196-001 9050302*PED 2033-09-15 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021196-001 9486426*PED 2033-09-15 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021196-001 10213400 2033-03-15 U-2499 2019-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021196-001 10864181 2033-03-15 U-1532 2021-01-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021196-001 11253494 2033-03-15 U-3323 2022-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021196-001 11253494 2033-03-15 U-3324 2022-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021196-001 11986446 2033-03-15 U-3324 2024-06-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021196-001 8772306 2033-03-15 U-1532 2014-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021196-001 9050302 2033-03-15 U-1532 2015-07-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021196-001 9486426 2033-03-15 U-1532 2016-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021196-001 10213400*PED 2033-09-15 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021196-001 10864181*PED 2033-09-15 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021196-001 11253494*PED 2033-09-15 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021196-001 8772306*PED 2033-09-15 Pediatric extension 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 105 observed states.
Additional Listing Data#
Finished product Yes
Brand name base sodium oxybate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM OXYBATE .5 g/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7G33012534 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349482 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-9628-57 sodium oxybate 180 mL in 1 BOTTLE, PLASTIC SOLUTION 180 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-9628 SODIUM OXYBATE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 5 Current NDC, Legacy NDC, 1 package rows 20240817_bcef2c95-35e9-464d-9025-652acff769e7.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-9628-57 00054962857 180 mL in 1 BOTTLE, PLASTIC (0054-9628-57) 180 ml 2023-01-03 0000-00-00 No No Current