NALTREXONE HYDROCHLORIDE
- Product NDC
- 71335-2062
- 11-digit product format
- 713352062
- Labeler code
- 71335
- Product ID
- 71335-2062_ab44332a-6f04-4f07-8209-e472206d5707
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NALTREXONE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090356
- Marketing category
- ANDA
- Marketing start
- 2012-02-29
- 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 |
|---|
| NALTREXONE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | Z6375YW9SF |
| Rxcui | 1483744 |
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-2062-1 | 71335206201 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2062-1) | 2022-03-21 | 0000-00-00 | No | No | Current |
| 71335-2062-2 | 71335206202 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2062-2) | 2022-03-21 | 0000-00-00 | No | No | Current |
| 71335-2062-3 | 71335206203 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2062-3) | 2022-03-21 | 0000-00-00 | No | No | Current |
| 71335-2062-4 | 71335206204 | 45 TABLET, FILM COATED in 1 BOTTLE (71335-2062-4) | 2022-03-21 | 0000-00-00 | No | No | Current |
| 71335-2062-5 | 71335206205 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-2062-5) | 2022-03-21 | 0000-00-00 | No | No | Current |
| 71335-2062-6 | 71335206206 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-2062-6) | 2022-03-21 | 0000-00-00 | No | No | Current |