gocovri

Generic: amantadine

Labeler: supernus pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gocovri
Generic Name amantadine
Labeler supernus pharmaceuticals
Dosage Form CAPSULE, COATED PELLETS
Routes
ORAL
Active Ingredients

amantadine 68.5 mg/1

Manufacturer
Supernus Pharmaceuticals

Identifiers & Regulatory

Product NDC 17772-085
Product ID 17772-085_4af3ee09-faf9-9840-e063-6394a90aafdc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208944
Listing Expiration 2027-12-31
Marketing Start 2017-08-24

Pharmacologic Class

Established (EPC)
influenza a m2 protein inhibitor [epc]
Mechanism of Action
m2 protein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 17772085
Hyphenated Format 17772-085

Supplemental Identifiers

RxCUI
1944370 1944376 1944380 1944382
UNII
BF4C9Z1J53
NUI
N0000175543 N0000175542

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name gocovri (source: ndc)
Generic Name amantadine (source: ndc)
Application Number NDA208944 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 68.5 mg/1
source: ndc
Packaging
  • 21 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-21)
  • 60 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-60)
source: ndc

Packages (2)

17772-085-21 21 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-21) 17772-085-60 60 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-60)

Ingredients (1)

amantadine (68.5 mg/1)

Linked Drug Pages (1)

GOCOVRI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4af3ee09-faf9-9840-e063-6394a90aafdc", "openfda": {"nui": ["N0000175543", "N0000175542"], "unii": ["BF4C9Z1J53"], "rxcui": ["1944370", "1944376", "1944380", "1944382"], "spl_set_id": ["2bee0631-0028-1314-e063-6394a90aaaed"], "pharm_class_epc": ["Influenza A M2 Protein Inhibitor [EPC]"], "pharm_class_moa": ["M2 Protein Inhibitors [MoA]"], "manufacturer_name": ["Supernus Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "21 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-21)", "package_ndc": "17772-085-21", "marketing_start_date": "20170824"}, {"sample": false, "description": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-60)", "package_ndc": "17772-085-60", "marketing_start_date": "20170824"}], "brand_name": "GOCOVRI", "product_id": "17772-085_4af3ee09-faf9-9840-e063-6394a90aafdc", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "17772-085", "generic_name": "AMANTADINE", "labeler_name": "Supernus Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GOCOVRI", "active_ingredients": [{"name": "AMANTADINE", "strength": "68.5 mg/1"}], "application_number": "NDA208944", "marketing_category": "NDA", "marketing_start_date": "20170824", "listing_expiration_date": "20271231"}