Naltrexone Hydrochloride
- Product NDC
- 64850-300
- 11-digit product format
- 648500300
- Labeler code
- 64850
- Product ID
- 64850-300_cae1ac14-ab22-42d1-8449-5e36c137b905
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naltrexone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Elite Laboratories, Inc.
- Application
- ANDA075274
- Marketing category
- ANDA
- Marketing start
- 2025-08-15
- 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NALTREXONE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Z6375YW9SF |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64850-300-01 | Naltrexone Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 64850-300-30 | Naltrexone Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 64850-300-01 | 64850030001 | 100 TABLET, FILM COATED in 1 BOTTLE (64850-300-01) | 2025-08-15 | No | No | Historical |
| 64850-300-30 | 64850030030 | 30 TABLET, FILM COATED in 1 BOTTLE (64850-300-30) | 2025-08-15 | No | No | Historical |