NDC 60505-2542

Galantamine

Galantamine Hydrobromide

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

Product ID60505-2542_79df63ff-f9b2-8565-537b-c5d3f757f35c
NDC60505-2542
Product TypeHuman Prescription Drug
Proprietary NameGalantamine
Generic NameGalantamine Hydrobromide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-11-05
Marketing CategoryANDA / ANDA
Application NumberANDA077781
Labeler NameApotex Corp.
Substance NameGALANTAMINE HYDROBROMIDE
Active Ingredient Strength4 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 60505-2542-6

60 TABLET, FILM COATED in 1 BOTTLE (60505-2542-6)
Marketing Start Date2012-11-05
Marketing End Date2021-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-2542-6 [60505254206]

Galantamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077781
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-11-05
Marketing End Date2021-11-30

NDC 60505-2542-3 [60505254203]

Galantamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077781
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-05
Marketing End Date2013-11-05

NDC 60505-2542-0 [60505254200]

Galantamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077781
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-05
Marketing End Date2013-11-05

NDC 60505-2542-8 [60505254208]

Galantamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077781
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-05
Marketing End Date2013-11-05

Drug Details

Active Ingredients

IngredientStrength
GALANTAMINE HYDROBROMIDE4 mg/1

OpenFDA Data

SPL SET ID:fa3cb01f-85bf-5cc8-7cf3-650d8729078c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 579148
  • 310437
  • 310436
  • UPC Code
  • 0360505254262
  • 0360505254361
  • 0360505254460
  • Pharmacological Class

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

    Medicade Reported Pricing

    60505254206 GALANTAMINE HBR 4 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    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
    68084-729GalantamineGalantamine
    68382-177galantaminegalantamine
    68382-178galantaminegalantamine
    68382-179galantaminegalantamine
    70436-005GalantamineGalantamine
    70436-004GalantamineGalantamine
    70436-006GalantamineGalantamine
    51079-853GalantamineGalantamine
    51079-852GalantamineGalantamine
    57237-051GalantamineGalantamine
    57237-049GalantamineGalantamine
    57237-050GalantamineGalantamine
    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
    0054-0137Galantamine HydrobromideGalantamine Hydrobromide
    10147-0881galantamine hydrobromidegalantamine hydrobromide
    10147-0882galantamine hydrobromidegalantamine hydrobromide

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