amantadine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Inc.. The primary component is Amantadine Hydrochloride.
| Product ID | 62332-246_550a314f-951f-4189-87e0-7488de10c932 |
| NDC | 62332-246 |
| Product Type | Human Prescription Drug |
| Proprietary Name | amantadine |
| Generic Name | Amantadine |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-06-22 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA208966 |
| Labeler Name | Alembic Pharmaceuticals Inc. |
| Substance Name | AMANTADINE HYDROCHLORIDE |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2017-06-22 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA208966 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-06-22 |
| Marketing Category | ANDA |
| Application Number | ANDA208966 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-06-22 |
| Marketing Category | ANDA |
| Application Number | ANDA208966 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-06-22 |
| Marketing Category | ANDA |
| Application Number | ANDA208966 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-06-22 |
| Ingredient | Strength |
|---|---|
| AMANTADINE HYDROCHLORIDE | 100 mg/1 |
| SPL SET ID: | 4157d9a7-a53f-4dde-b051-fe3e9a674913 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 46708-246 | amantadine | amantadine |
| 46708-586 | Amantadine | Amantadine |
| 60687-422 | Amantadine | Amantadine |
| 62332-246 | amantadine | amantadine |
| 62332-586 | Amantadine | Amantadine |
| 70482-085 | GOCOVRI | AMANTADINE |
| 70482-170 | GOCOVRI | AMANTADINE |
| 68025-021 | Osmolex ER | amantadine |
| 68025-074 | Osmolex ER | amantadine |
| 68025-075 | Osmolex ER | amantadine |
| 68025-076 | Osmolex ER | amantadine |
| 68025-077 | Osmolex ER | amantadine |
| 70482-075 | OSMOLEX ER | amantadine |
| 70482-076 | OSMOLEX ER | amantadine |