NALTREXONE HYDROCHLORIDE
- Product NDC
- 71335-1480
- 11-digit product format
- 713351480
- Labeler code
- 71335
- Product ID
- 71335-1480_63da50ae-3486-4314-bbfd-dd0ba473bfdc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naltrexone hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA076264
- Marketing category
- ANDA
- Marketing start
- 2002-03-22
- 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 |
|---|
| 71335-1480-1 | NALTREXONE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 71335-1480-2 | NALTREXONE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
| 71335-1480-3 | NALTREXONE HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 71335-1480-4 | NALTREXONE HYDROCHLORIDE | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 4 |
| 71335-1480-5 | NALTREXONE HYDROCHLORIDE | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 4 |
| 71335-1480-6 | NALTREXONE HYDROCHLORIDE | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1480 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 4 | Current NDC, Legacy NDC, 6 package rows | 20240602_838a1e88-1179-4a2a-a737-8ce008bb96a7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1480-1 | 71335148001 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1480-1) | 2020-01-16 | 0000-00-00 | No | No | Current |
| 71335-1480-2 | 71335148002 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1480-2) | 2020-01-22 | 0000-00-00 | No | No | Current |
| 71335-1480-3 | 71335148003 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1480-3) | 2024-05-30 | 0000-00-00 | No | No | Current |
| 71335-1480-4 | 71335148004 | 45 TABLET, FILM COATED in 1 BOTTLE (71335-1480-4) | 2024-05-30 | 0000-00-00 | No | No | Current |
| 71335-1480-5 | 71335148005 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1480-5) | 2024-05-30 | 0000-00-00 | No | No | Current |
| 71335-1480-6 | 71335148006 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1480-6) | 2020-09-10 | 0000-00-00 | No | No | Current |