NALTREXONE HYDROCHLORIDE
- Product NDC
- 68084-291
- 11-digit product format
- 680840291
- Labeler code
- 68084
- Product ID
- 68084-291_1ef27c71-786e-4f5e-e063-6294a90a7934
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naltrexone hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA076264
- Marketing category
- ANDA
- Marketing start
- 2013-06-03
- 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 |
|---|
| 68084-291-11 | NALTREXONE HYDROCHLORIDE | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 10 |
| 68084-291-21 | NALTREXONE HYDROCHLORIDE | 30 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 30 | | 10 |
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 [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 |
|---|
| 68084-291 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240806_81e25c6a-81b6-4cfb-91bf-be20c3ae546b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68084-291-11 | 68084029111 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 68084-291-21 | 68084029121 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-291-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-291-11) | 30 blister pack | 2013-06-03 | 0000-00-00 | No | No | Current |