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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| Z6375YW9SF | NALTREXONE HYDROCHLORIDE | 16676-29-2 | NALTREXONE HYDROCHLORIDE |
Packages
| 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 | Historical |