Prescription drug · ANDA
Sodium Oxybate NDC 65162-065
Sodium oxybate 500 mg/mL · Solution · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-065-87 | 65162006587 | 1 BOTTLE in 1 CARTON (65162-065-87) / 180 mL in 1 BOTTLEMarketed from Sep 12, 2025 |
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 — 500 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203631
- 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 65162-065_fb0e7d54-bf58-46d7-8561-9a270771f0d2SPL ID fb0e7d54-bf58-46d7-8561-9a270771f0d2SPL set ID 5a9e9045-f04d-46eb-8396-2495c6090a31RxCUI 349482UNII 7G33012534UPC 0365162065879
- 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
N465162006587followed by a unit qualifier and the quantityPackage 65162-0065-87. 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 solution 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.