Naltrexone Hydrochloride
- Product NDC
- 70518-4344
- 11-digit product format
- 705184344
- Labeler code
- 70518
- Product ID
- 70518-4344_4031031d-3b90-1644-e063-6294a90ae5a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naltrexone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA075274
- Marketing category
- ANDA
- Marketing start
- 2025-05-20
- 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 |
|---|
| 70518-4344-0 | Naltrexone Hydrochloride | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4344 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20250523_db911559-26f5-43a0-b61f-3425176c936f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4344-0 | 70518434400 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4344-0) | 2025-05-20 | No | No | Historical |