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
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 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 |
|---|
| 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 |
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 |