NALTREXONE HYDROCHLORIDE
- Product NDC
- 0615-8579
- 11-digit product format
- 006158579
- Labeler code
- 0615
- Product ID
- 0615-8579_cdb406b8-353a-42e0-be3d-076d2d789ddc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NALTREXONE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA090356
- Marketing category
- ANDA
- Marketing start
- 2012-02-29
- 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 |
|---|
| 0615-8579-39 | NALTREXONE HYDROCHLORIDE | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8579-39 | 00615857939 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8579-39) | 2025-08-27 | No | No | Historical |