sodium oxybate
- Product NDC
- 0054-9628
- 11-digit product format
- 000549628
- Labeler code
- 0054
- Product ID
- 0054-9628_599719a1-b644-4ece-b0c0-ce8d85378e01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sodium oxybate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA021196
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2023-01-03
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- sodium oxybate
- Listing expiration
- 2026-12-31
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 |
|---|
| 0054-9628-57 | sodium oxybate | 180 mL in 1 BOTTLE, PLASTIC | SOLUTION | 180 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-9628 | SODIUM OXYBATE SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240817_bcef2c95-35e9-464d-9025-652acff769e7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-9628-57 | 00054962857 | 180 mL in 1 BOTTLE, PLASTIC (0054-9628-57) | 180 ml | 2023-01-03 | 0000-00-00 | No | No | Current |