Naltrexone Hydrochloride
- Product NDC
- 16729-081
- 11-digit product format
- 167290081
- Labeler code
- 16729
- Product ID
- 16729-081_424db74c-6c0f-1eb3-e063-6294a90a7db8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naltrexone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Accord Healthcare, Inc.
- 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
- 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 |
|---|
| 16729-081-01 | Naltrexone Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 5 |
| 16729-081-10 | Naltrexone Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 16729-081-16 | Naltrexone Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 5 |
| 16729-081-17 | Naltrexone Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 5 |
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 [ACCORD HEALTHCARE, INC.] | 2 | |
| NALTREXONE | ACTIVE MOIETY | 5S6W795CQM | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 2 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-081 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240216_49aa3d6d-2270-4615-aafa-b440859ab870.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 |
|---|
| 16729-081-01 | 16729008101 | 100 TABLET, FILM COATED in 1 BOTTLE (16729-081-01) | 2012-01-18 | 0000-00-00 | No | No | Current |
| 16729-081-10 | 16729008110 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-081-10) | 2012-01-18 | 0000-00-00 | No | No | Current |
| 16729-081-16 | 16729008116 | 500 in 1 BOTTLE | | | | | Historical |
| 16729-081-17 | 16729008117 | 1000 in 1 BOTTLE | | | | | Historical |