NALTREXONE HYDROCHLORIDE
- Product NDC
- 0406-1170
- 11-digit product format
- 004061170
- Labeler code
- 0406
- Product ID
- 0406-1170_9ed13551-325e-4b82-a266-72fc89ed27dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naltrexone hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- SpecGx LLC
- 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 |
|---|
| 0406-1170-01 | NALTREXONE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 14 |
| 0406-1170-03 | NALTREXONE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NALTREXONE HYDROCHLORIDE | ACTIVE INGREDIENT | Z6375YW9SF | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.] | 7 | |
| NALTREXONE | ACTIVE MOIETY | 5S6W795CQM | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.] | 7 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.] | 7 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.] | 7 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.] | 7 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.] | 7 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [MALLINCKRODT, INC.] | 7 | |
| NALTREXONE HYDROCHLORIDE | ACTIVE INGREDIENT | Z6375YW9SF | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| NALTREXONE | ACTIVE MOIETY | 5S6W795CQM | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0406-1170 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [SPECGX LLC] | 14 | Current NDC, Legacy NDC, 2 package rows | 20240503_06ff2d5a-e62b-4fa4-bbdb-01938535bc65.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 |
|---|
| 0406-1170-01 | 00406117001 | 100 TABLET, FILM COATED in 1 BOTTLE (0406-1170-01) | 2002-03-22 | 0000-00-00 | No | No | Current |
| 0406-1170-03 | 00406117003 | 30 TABLET, FILM COATED in 1 BOTTLE (0406-1170-03) | 2002-03-22 | 0000-00-00 | No | No | Current |