Naltrexone Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Naltrexone Hydrochloride.
| Product ID | 71335-0014_5823cedf-6a36-48c4-8c53-b4f882ae25f9 |
| NDC | 71335-0014 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Naltrexone Hydrochloride |
| Generic Name | Naltrexone Hydrochloride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2012-01-18 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA091205 |
| Labeler Name | Bryant Ranch Prepack |
| Substance Name | NALTREXONE HYDROCHLORIDE |
| Active Ingredient Strength | 50 mg/1 |
| Pharm Classes | Opioid Antagonist [EPC],Opioid Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2017-08-08 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA091205 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-08-08 |
| Marketing Category | ANDA |
| Application Number | ANDA091205 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-08-08 |
| Marketing Category | ANDA |
| Application Number | ANDA091205 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-08-08 |
| Marketing Category | ANDA |
| Application Number | ANDA091205 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-08-08 |
| Marketing Category | ANDA |
| Application Number | ANDA091205 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-08-08 |
| Marketing Category | ANDA |
| Application Number | ANDA091205 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-08-08 |
| Ingredient | Strength |
|---|---|
| NALTREXONE HYDROCHLORIDE | 50 mg/1 |
| SPL SET ID: | fa0b0881-97f3-4ca2-bc15-0954293081db |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0406-1170 | NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride |
| 0904-7036 | NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE |
| 16729-081 | Naltrexone Hydrochloride | Naltrexone Hydrochloride |
| 42291-632 | Naltrexone Hydrochloride | Naltrexone Hydrochloride |
| 47335-326 | NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE |
| 50090-2866 | Naltrexone Hydrochloride | Naltrexone Hydrochloride |
| 50090-3076 | Naltrexone Hydrochloride | Naltrexone Hydrochloride |
| 50090-3929 | NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE |
| 50090-4925 | Naltrexone Hydrochloride | Naltrexone Hydrochloride |
| 50090-4926 | Naltrexone Hydrochloride | Naltrexone Hydrochloride |
| 51224-206 | Naltrexone Hydrochloride | Naltrexone Hydrochloride |
| 53217-261 | Naltrexone Hydrochloride | Naltrexone Hydrochloride |
| 62135-242 | Naltrexone Hydrochloride | Naltrexone Hydrochloride |
| 63629-1046 | Naltrexone Hydrochloride | Naltrexone Hydrochloride |
| 63629-1047 | Naltrexone Hydrochloride | Naltrexone Hydrochloride |
| 68071-2156 | Naltrexone Hydrochloride | Naltrexone Hydrochloride |
| 68071-2721 | Naltrexone Hydrochloride | Naltrexone Hydrochloride |
| 68084-291 | NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride |
| 68094-853 | Naltrexone Hydrochloride | naltrexone Hydrochloride |
| 68788-7084 | Naltrexone Hydrochloride | Naltrexone Hydrochloride |
| 70518-1146 | Naltrexone Hydrochloride | Naltrexone Hydrochloride |
| 70518-1312 | NALTREXONE HYDROCHLORIDE | naltrexone hydrochloride |
| 70518-2718 | NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE |
| 71335-0014 | Naltrexone Hydrochloride | Naltrexone Hydrochloride |
| 76519-1160 | NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE |
| 71335-1480 | NALTREXONE HYDROCHLORIDE | NALTREXONE HYDROCHLORIDE |