Prescription drug · ANDA
sodium oxybate NDC 31722-891
Sodium oxybate .5 g/mL · Solution · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-891-18 | 31722089118 | 1 BOTTLE in 1 CARTON (31722-891-18) / 180 mL in 1 BOTTLEMarketed from Jan 1, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- sodium oxybate
- Generic name (nonproprietary)
- sodium oxybate
- Active ingredients
- Sodium oxybate — .5 g/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210523
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Central Nervous System Depression (Physiologic effect)Decreased Central Nervous System Organized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 31722-891_ed6f9595-7f10-4822-8dca-57b219fffe50SPL ID ed6f9595-7f10-4822-8dca-57b219fffe50SPL set ID 5dcf9a5c-312b-420b-82f3-42177d8f9ee4RxCUI 349482UNII 7G33012534UPC 0331722891189
- Pharmacologic class
- Central Nervous System Depressant
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N431722089118followed by a unit qualifier and the quantityPackage 31722-0891-18. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Sodium oxybate oral solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy. Pediatric use information is approved for Jazz Pharmaceuticals Inc.’s XYREM (sodium oxybate) Oral Solution. However, due to Jazz Pharmaceuticals Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Sodium oxybate oral solutio n is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy (1).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210523
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| sodium oxybate | Sodium oxybate .5 g/mL | SolutionOral | XLCare Pharmaceuticals, Inc. | 72865-349 |