Naltrexone Hydrochloride
- Product NDC
- 42291-632
- 11-digit product format
- 422910632
- Labeler code
- 42291
- Product ID
- 42291-632_4a197f32-b382-2a52-e063-6394a90ad197
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naltrexone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA075274
- Marketing category
- ANDA
- Marketing start
- 2015-03-26
- Marketing end
- 2028-06-30
- Substance
- NALTREXONE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naltrexone Hydrochloride
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 |
|---|
| 42291-632-30 | Naltrexone Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 10 |
| 42291-632-60 | Naltrexone Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Naltrexone Hydrochloride | ACTIVE INGREDIENT | Z6375YW9SF | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| Naltrexone | ACTIVE MOIETY | 5S6W795CQM | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| anhydrous lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| hydroxypropyl cellulose (type h) | INACTIVE INGREDIENT | RFW2ET671P | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-632 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AVKARE] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240802_21b43dab-015c-c82f-ba6e-27da0ec12fc5.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 |
|---|
| 42291-632-30 | 42291063230 | 30 TABLET, FILM COATED in 1 BOTTLE (42291-632-30) | 2015-03-26 | 2028-06-30 | No | No | Current |
| 42291-632-60 | 42291063260 | 60 TABLET, FILM COATED in 1 BOTTLE (42291-632-60) | 2025-07-24 | 2028-06-30 | No | No | Historical |