Home NDC 31722-891 sodium oxybate
Product NDC 31722-891
11-digit product format 317220891
Labeler code 31722
Product ID 31722-891_cd5e0e58-4136-450e-b3bc-c63ffcfc1d94
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sodium oxybate
Dosage form SOLUTION
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA210523
Marketing category ANDA
Marketing start 2026-01-01
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 2027-12-31
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 A210523-001 SODIUM OXYBATE SODIUM OXYBATE 0.5GM/ML SOLUTION / ORAL AA 2025-11-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210523-001 AA
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.
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 A210523-001 SODIUM OXYBATE 0.5GM/ML SOLUTION / ORAL AA 2025-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210523-001 SODIUM OXYBATE 0.5GM/ML SOLUTION / ORAL AA 2025-11-05 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210523-001 SODIUM OXYBATE 0.5GM/ML SOLUTION / ORAL AA 2025-11-05 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A210523-001 AA 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210523-001 AA 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210523-001 AA 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base sodium oxybate
Listing expiration 2027-12-31 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 31722-891-18 sodium oxybate 1 in 1 CARTON SOLUTION 1 2 31722-891-18 sodium oxybate 180 mL in 1 BOTTLE SOLUTION 180 2
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 31722-891-18 31722089118 1 BOTTLE in 1 CARTON (31722-891-18) / 180 mL in 1 BOTTLE 1 bottle 2026-01-01 No No Current