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 ID70482-085_67122e7c-15e7-463b-b7b5-89ceaa5c0472
NDC70482-085
Product TypeHuman Prescription Drug
Proprietary NameGOCOVRI
Generic NameAmantadine
Dosage FormCapsule, Coated Pellets
Route of AdministrationORAL
Marketing Start Date2017-08-24
Marketing CategoryNDA / NDA
Application NumberNDA208944
Labeler NameAdamas Pharma, LLC
Substance NameAMANTADINE
Active Ingredient Strength69 mg/1
Pharm ClassesInfluenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70482-085-21

21 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-21)
Marketing Start Date2017-08-24
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 70482-085-60 [70482008560]

GOCOVRI CAPSULE, COATED PELLETS
Marketing CategoryNDA
Application NumberNDA208944
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-24

Drug Details

Active Ingredients

IngredientStrength
AMANTADINE68.5 mg/1

OpenFDA Data

SPL SET ID:82ff865f-78f3-4c94-b6a9-727a54944b28
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1944382
  • 1944376
  • 1944380
  • 1944370
  • Pharmacological Class

    • Influenza A M2 Protein Inhibitor [EPC]
    • M2 Protein Inhibitors [MoA]

    NDC Crossover Matching brand name "GOCOVRI" or generic name "Amantadine"

    NDCBrand NameGeneric Name
    70482-085GOCOVRIAMANTADINE
    70482-170GOCOVRIAMANTADINE
    46708-246amantadineamantadine
    46708-586AmantadineAmantadine
    60687-422AmantadineAmantadine
    62332-246amantadineamantadine
    62332-586AmantadineAmantadine
    68025-021Osmolex ERamantadine
    68025-074Osmolex ERamantadine
    68025-075Osmolex ERamantadine
    68025-076Osmolex ERamantadine
    68025-077Osmolex ERamantadine
    70482-075OSMOLEX ERamantadine
    70482-076OSMOLEX ERamantadine

    Trademark Results [GOCOVRI]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GOCOVRI
    GOCOVRI
    86698587 5649541 Live/Registered
    Adamas Pharmaceuticals, Inc.
    2015-07-20

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