NDC 60687-422

Amantadine

Amantadine

Amantadine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by American Health Packaging. The primary component is Amantadine Hydrochloride.

Product ID60687-422_849c8cb5-2205-3db6-e053-2991aa0a0357
NDC60687-422
Product TypeHuman Prescription Drug
Proprietary NameAmantadine
Generic NameAmantadine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA208966
Labeler NameAmerican Health Packaging
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 60687-422-01

100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-422-01) > 1 CAPSULE in 1 BLISTER PACK (60687-422-11)
Marketing Start Date2019-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60687-422-11 [60687042211]

Amantadine CAPSULE
Marketing CategoryANDA
Application NumberANDA208966
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-01

NDC 60687-422-01 [60687042201]

Amantadine CAPSULE
Marketing CategoryANDA
Application NumberANDA208966
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-01

Drug Details

Active Ingredients

IngredientStrength
AMANTADINE HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:5119801d-a5cb-4adf-96b2-08cc3a0ba594
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 849389
  • Pharmacological Class

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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.