Naltrexone Hydrochloride
- Product NDC
- 71335-2743
- 11-digit product format
- 713352743
- Labeler code
- 71335
- Product ID
- 71335-2743_65118794-da2b-4d50-aebb-caa45e7e478d
- 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
- 2024-02-15
- 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
openFDA Listing Details
- Product ID
- 71335-2743_65118794-da2b-4d50-aebb-caa45e7e478d
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Naltrexone Hydrochloride
- Generic name
- Naltrexone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2024-02-15
- Marketing category
- ANDA
- Application number
- ANDA075274
- Pharmacologic classes
- Opioid Antagonist [EPC]; Opioid Antagonists [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| NALTREXONE HYDROCHLORIDE | 50 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | Z6375YW9SF |
| Rxcui | 1483744 |
| Spl Set Id | 68cb0399-ca56-4310-8531-6b5552b71b25 |
| Manufacturer Name | Bryant Ranch Prepack |
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 |
|---|
| 71335-2743-1 | 71335274301 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2743-1) | 2025-07-29 | No | No | Current |