NALTREXONE HYDROCHLORIDE
- Product NDC
- 71610-919
- 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
- Substance
- NALTREXONE HYDROCHLORIDE
- Current FDA listing
- Yes
Related Records
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|---|---|---|---|---|
| 71610-919-31 | 600 TABLET, FILM COATED in 1 BOTTLE (71610-919-31) | 2025-07-01 | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|---|---|---|---|
| Naltrexone Hydrochloride Tablets USP 50 mg Opioid Antagonist Rx only | Aphena Pharma Solutions - Tennessee, LLC | 2025-07-03 | HUMAN PRESCRIPTION DRUG LABEL | 1 |