Sodium Oxybate
- Product NDC
- 65162-065
- 11-digit product format
- 651620065
- Labeler code
- 65162
- Product ID
- 65162-065_fb0e7d54-bf58-46d7-8561-9a270771f0d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Oxybate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA203631
- Marketing category
- ANDA
- Marketing start
- 2025-09-12
- Substance
- SODIUM OXYBATE
- Active strength
- 500 mg/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
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 | 500 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7G33012534 |
| Rxcui | 349482 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-065-87 | Sodium Oxybate | 180 mL in 1 BOTTLE | SOLUTION | 180 | | 19 |
| 65162-065-87 | Sodium Oxybate | 1 in 1 CARTON | SOLUTION | 1 | | 19 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65162-065-87 | 65162006587 | 1 BOTTLE in 1 CARTON (65162-065-87) / 180 mL in 1 BOTTLE | 1 bottle | 2025-09-12 | No | No | Historical |