Naltrexone Hydrochloride
- Product NDC
- 68071-3654
- 11-digit product format
- 680713654
- Labeler code
- 68071
- Product ID
- 68071-3654_2a2ff668-e2bb-5308-e063-6294a90a832d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naltrexone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals Inc.
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naltrexone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NALTREXONE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Z6375YW9SF |
| Rxcui | 1483744 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3654-3 | Naltrexone Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3654 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS INC.] | 2 | Current NDC, 1 package rows | 20241228_1e059495-5e64-0cb0-e063-6394a90a3ffc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3654-3 | 68071365403 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3654-3) | 2024-07-24 | No | No | Historical |