NDC 70482-085
GOCOVRI
Amantadine
GOCOVRI is a Oral Capsule, Coated Pellets in the Human Prescription Drug category. It is labeled and distributed by Adamas Pharma, Llc. The primary component is Amantadine.
| Product ID | 70482-085_67122e7c-15e7-463b-b7b5-89ceaa5c0472 |
| NDC | 70482-085 |
| Product Type | Human Prescription Drug |
| Proprietary Name | GOCOVRI |
| Generic Name | Amantadine |
| Dosage Form | Capsule, Coated Pellets |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-08-24 |
| Marketing Category | NDA / NDA |
| Application Number | NDA208944 |
| Labeler Name | Adamas Pharma, LLC |
| Substance Name | AMANTADINE |
| Active Ingredient Strength | 69 mg/1 |
| Pharm Classes | Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 70482-085-21
21 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-21)
| Marketing Start Date | 2017-08-24 |
| NDC Exclude Flag | N |
| Sample Package? | Y |
NDC SPL Data Element Entries
NDC 70482-085-60 [70482008560]
GOCOVRI CAPSULE, COATED PELLETS
| Marketing Category | NDA |
| Application Number | NDA208944 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-08-24 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| AMANTADINE | 68.5 mg/1 |
OpenFDA Data
| SPL SET ID: | 82ff865f-78f3-4c94-b6a9-727a54944b28 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Influenza A M2 Protein Inhibitor [EPC]
- M2 Protein Inhibitors [MoA]
NDC Crossover Matching brand name "GOCOVRI" or generic name "Amantadine"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 70482-085 | GOCOVRI | AMANTADINE |
| 70482-170 | GOCOVRI | AMANTADINE |
| 46708-246 | amantadine | amantadine |
| 46708-586 | Amantadine | Amantadine |
| 60687-422 | Amantadine | Amantadine |
| 62332-246 | amantadine | amantadine |
| 62332-586 | Amantadine | 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 |
Trademark Results [GOCOVRI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GOCOVRI 86698587 5649541 Live/Registered |
Adamas Pharmaceuticals, Inc. 2015-07-20 |
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