Naltrexone Hydrochloride
- Product NDC
- 71335-3104
- 11-digit product format
- 713353104
- Labeler code
- 71335
- Product ID
- 71335-3104_efa09603-93f0-42f9-9a40-239e59ebbcee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naltrexone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075274
- Marketing category
- ANDA
- Marketing start
- 2013-09-23
- Marketing end
- 2027-11-30
- Substance
- NALTREXONE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naltrexone Hydrochloride
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 |
|---|
| 71335-3104-1 | Naltrexone Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 71335-3104-2 | Naltrexone Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
| 71335-3104-3 | Naltrexone Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 71335-3104-4 | Naltrexone Hydrochloride | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | | 1 |
| 71335-3104-5 | Naltrexone Hydrochloride | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 1 |
| 71335-3104-6 | Naltrexone Hydrochloride | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 1 |
| 71335-3104-7 | Naltrexone Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
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 |
|---|
| 71335-3104-1 | 71335310401 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-3104-1) | 2026-03-16 | 2027-11-30 | No | No | Historical |
| 71335-3104-2 | 71335310402 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-3104-2) | 2026-03-16 | 2027-11-30 | No | No | Historical |
| 71335-3104-3 | 71335310403 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-3104-3) | 2026-03-16 | 2027-11-30 | No | No | Historical |
| 71335-3104-4 | 71335310404 | 45 TABLET, FILM COATED in 1 BOTTLE (71335-3104-4) | 2026-03-16 | 2027-11-30 | No | No | Historical |
| 71335-3104-5 | 71335310405 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-3104-5) | 2026-03-16 | 2027-11-30 | No | No | Historical |
| 71335-3104-6 | 71335310406 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-3104-6) | 2026-03-16 | 2027-11-30 | No | No | Historical |
| 71335-3104-7 | 71335310407 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-3104-7) | 2026-03-16 | 2027-11-30 | No | No | Historical |