Naltrexone Hydrochloride
- Product NDC
- 50090-4925
- 11-digit product format
- 500904925
- Labeler code
- 50090
- Product ID
- 50090-4925_4242e317-1764-436a-aff6-338a58f1b0a2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naltrexone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA091205
- Marketing category
- ANDA
- Marketing start
- 2012-01-18
- Substance
- NALTREXONE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naltrexone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NALTREXONE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Z6375YW9SF |
| Rxcui | 1483744 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-4925-0 | Naltrexone Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-4925 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 5 | Current NDC, Legacy NDC, 1 package rows | 20231216_00c04ff4-b6f2-466c-9ab9-813a60577db0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-4925-0 | 50090492500 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-4925-0) | 2020-02-20 | 0000-00-00 | No | No | Current |