Naltrexone Hydrochloride
- Product NDC
- 71335-0014
- 11-digit product format
- 713350014
- Labeler code
- 71335
- Product ID
- 71335-0014_63e4eb6a-b262-44d1-974b-633876a9c563
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naltrexone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA091205
- Marketing category
- ANDA
- Marketing start
- 2012-01-18
- Substance
- NALTREXONE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naltrexone Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 71335-0014-1 | Naltrexone Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 13 |
| 71335-0014-2 | Naltrexone Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 13 |
| 71335-0014-3 | Naltrexone Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 13 |
| 71335-0014-4 | Naltrexone Hydrochloride | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 13 |
| 71335-0014-5 | Naltrexone Hydrochloride | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 13 |
| 71335-0014-6 | Naltrexone Hydrochloride | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 13 |
| 71335-0014-7 | Naltrexone Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0014 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 12 | Current NDC, Legacy NDC, 7 package rows | 20240510_fa0b0881-97f3-4ca2-bc15-0954293081db.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 |
|---|
| 71335-0014-1 | 71335001401 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0014-1) | 2026-05-14 | 0000-00-00 | No | No | Current |
| 71335-0014-2 | 71335001402 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0014-2) | 2026-05-14 | 0000-00-00 | No | No | Current |
| 71335-0014-3 | 71335001403 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0014-3) | 2026-05-14 | 0000-00-00 | No | No | Current |
| 71335-0014-4 | 71335001404 | 45 TABLET, FILM COATED in 1 BOTTLE (71335-0014-4) | 2026-05-14 | 0000-00-00 | No | No | Current |
| 71335-0014-5 | 71335001405 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-0014-5) | 2026-05-14 | 0000-00-00 | No | No | Current |
| 71335-0014-6 | 71335001406 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-0014-6) | 2026-05-14 | 0000-00-00 | No | No | Current |
| 71335-0014-7 | 71335001407 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-0014-7) | 2026-05-14 | | No | No | Current |