Naltrexone Hydrochloride
- Product NDC
- 53401-008
- 11-digit product format
- 534010008
- Labeler code
- 53401
- Product ID
- 53401-008_4f721786-dab7-3405-e063-6294a90a6bbb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naltrexone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA075274
- Marketing category
- ANDA
- Marketing start
- 2015-03-26
- Marketing end
- 2028-06-30
- Substance
- NALTREXONE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naltrexone Hydrochloride
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 |
|---|
| 53401-008-31 | Naltrexone Hydrochloride | 600 in 1 BOTTLE | TABLET, FILM COATED | 600 | | 1 |
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 |
|---|
| 53401-008-31 | 53401000831 | 600 TABLET, FILM COATED in 1 BOTTLE (53401-008-31) | 2026-04-14 | 2028-06-30 | No | No | Historical |