NDC 46708-246

amantadine

Amantadine

amantadine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Amantadine Hydrochloride.

Product ID46708-246_2d607d4e-2e5b-41f0-be0f-dd2305f2d82b
NDC46708-246
Product TypeHuman Prescription Drug
Proprietary Nameamantadine
Generic NameAmantadine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-06-22
Marketing CategoryANDA / ANDA
Application NumberANDA208966
Labeler NameAlembic Pharmaceuticals Limited
Substance NameAMANTADINE HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesInfluenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 46708-246-30

30 CAPSULE in 1 BOTTLE (46708-246-30)
Marketing Start Date2017-06-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-246-30 [46708024630]

amantadine CAPSULE
Marketing CategoryANDA
Application NumberANDA208966
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-22

NDC 46708-246-91 [46708024691]

amantadine CAPSULE
Marketing CategoryANDA
Application NumberANDA208966
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-22

NDC 46708-246-71 [46708024671]

amantadine CAPSULE
Marketing CategoryANDA
Application NumberANDA208966
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-22

NDC 46708-246-31 [46708024631]

amantadine CAPSULE
Marketing CategoryANDA
Application NumberANDA208966
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-22

Drug Details

Active Ingredients

IngredientStrength
AMANTADINE HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:d8887814-3e56-447e-8bc3-add1861e0cf7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849389
  • UPC Code
  • 0346708246303
  • Pharmacological Class

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

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

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

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