NDC 68084-729

Galantamine

Galantamine

Galantamine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by American Health Packaging. The primary component is Galantamine Hydrobromide.

Product ID68084-729_6d964c91-cc05-2883-e053-2a91aa0a913f
NDC68084-729
Product TypeHuman Prescription Drug
Proprietary NameGalantamine
Generic NameGalantamine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-06-11
Marketing CategoryANDA / ANDA
Application NumberANDA090957
Labeler NameAmerican Health Packaging
Substance NameGALANTAMINE HYDROBROMIDE
Active Ingredient Strength4 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68084-729-21

30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-729-21) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-729-11)
Marketing Start Date2014-06-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68084-729-11 [68084072911]

Galantamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090957
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-11

NDC 68084-729-21 [68084072921]

Galantamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090957
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-11

Drug Details

Active Ingredients

IngredientStrength
GALANTAMINE HYDROBROMIDE4 mg/1

OpenFDA Data

SPL SET ID:e80ec152-3616-4a13-9266-715550a8c398
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310436
  • Pharmacological Class

    • Cholinesterase Inhibitor [EPC]
    • Cholinesterase Inhibitors [MoA]

    Medicade Reported Pricing

    68084072921 GALANTAMINE HBR 4 MG TABLET

    Pricing Unit: EA | Drug Type:

    68084072911 GALANTAMINE HBR 4 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Galantamine" or generic name "Galantamine"

    NDCBrand NameGeneric Name
    0054-0090GalantamineGalantamine
    0054-0091GalantamineGalantamine
    0054-0092GalantamineGalantamine
    0378-2721Galantaminegalantamine
    0378-2722Galantaminegalantamine
    0378-2723Galantaminegalantamine
    0591-3496GalantamineGalantamine
    0591-3497GalantamineGalantamine
    0591-3498GalantamineGalantamine
    0615-7541GalantamineGalantamine
    0615-7542GalantamineGalantamine
    0615-7543GalantamineGalantamine
    0904-7104Galantaminegalantamine
    51079-852Galantaminegalantamine
    51079-853Galantaminegalantamine
    57237-049GalantamineGalantamine
    57237-050GalantamineGalantamine
    68084-729GalantamineGalantamine
    68382-177galantaminegalantamine
    68382-178galantaminegalantamine
    68382-179galantaminegalantamine
    70436-005GalantamineGalantamine
    70436-004GalantamineGalantamine
    70436-006GalantamineGalantamine
    57237-051GalantamineGalantamine
    60505-2542GalantamineGalantamine
    60505-2543GalantamineGalantamine
    60505-2544GalantamineGalantamine
    63739-708GalantamineGalantamine
    63739-999GalantamineGalantamine
    65862-458GalantamineGalantamine
    65862-745GalantamineGalantamine
    65841-755GalantamineGalantamine
    65862-459GalantamineGalantamine
    65862-460GalantamineGalantamine
    65862-746GalantamineGalantamine
    65841-756GalantamineGalantamine
    65841-757GalantamineGalantamine
    65862-744GalantamineGalantamine

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