NALTREXONE HYDROCHLORIDE
- Product NDC
- 71610-964
- 11-digit product format
- 716100964
- Labeler code
- 71610
- Product ID
- 71610-964_43cd684b-f17f-80ab-e063-6294a90a6f5a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naltrexone hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076264
- Marketing category
- ANDA
- Marketing start
- 2002-03-22
- 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 |
|---|
| 71610-964-31 | 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 | Sample | Exclude flag | Status |
|---|
| 71610-964-31 | 71610096431 | 600 TABLET, FILM COATED in 1 BOTTLE (71610-964-31) | 2025-11-13 | No | No | Current |