Naltrexone Hydrochloride
- Product NDC
- 71335-3012
- 11-digit product format
- 713353012
- Labeler code
- 71335
- Product ID
- 71335-3012_14ac2818-29aa-4225-8e02-48e0b3e189f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naltrexone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075274
- Marketing category
- ANDA
- Marketing start
- 2025-08-15
- 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 |
|---|
| 71335-3012-1 | 71335301201 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-3012-1) | 2025-11-18 | No | No | Historical |