Naltrexone Hydrochloride
- Product NDC
- 23155-886
- 11-digit product format
- 231550886
- Labeler code
- 23155
- Product ID
- 23155-886_6ffda82d-69f6-40f7-90fd-53b628440934
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naltrexone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc
- Application
- ANDA207905
- Marketing category
- ANDA
- Marketing start
- 2023-10-06
- 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 |
|---|
| 23155-886-01 | Naltrexone Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 23155-886-03 | 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 |
|---|
| 23155-886 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC D/B/A AVET PHARMACEUTICALS INC] | 1 | Current NDC, 2 package rows | 20231006_c67a22bb-d2bd-4da5-9d3e-6b5281f10891.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 23155-886-01 | 23155088601 | 100 TABLET, FILM COATED in 1 BOTTLE (23155-886-01) | 2023-10-06 | No | No | Current |
| 23155-886-03 | 23155088603 | 30 TABLET, FILM COATED in 1 BOTTLE (23155-886-03) | 2023-10-06 | No | No | Current |