| Product NDC: | 51079-481 |
| Proprietary Name: | Amantadine Hydrochloride |
| Non Proprietary Name: | amantadine hydrochloride |
| Active Ingredient(s): | 100 mg/1 & nbsp; amantadine hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE, GELATIN COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 51079-481 |
| Labeler Name: | Mylan Institutional Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA070589 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120809 |
| Package NDC: | 51079-481-20 |
| Package Description: | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-481-20) > 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (51079-481-01) |
| NDC Code | 51079-481-20 |
| Proprietary Name | Amantadine Hydrochloride |
| Package Description | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-481-20) > 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (51079-481-01) |
| Product NDC | 51079-481 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | amantadine hydrochloride |
| Dosage Form Name | CAPSULE, GELATIN COATED |
| Route Name | ORAL |
| Start Marketing Date | 20120809 |
| Marketing Category Name | ANDA |
| Labeler Name | Mylan Institutional Inc. |
| Substance Name | AMANTADINE HYDROCHLORIDE |
| Strength Number | 100 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA] |