NDC 0591-3497

Galantamine

Galantamine

Galantamine is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Galantamine Hydrobromide.

Product ID0591-3497_318d373a-e909-4d30-b9bd-60e136fe7569
NDC0591-3497
Product TypeHuman Prescription Drug
Proprietary NameGalantamine
Generic NameGalantamine
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2008-12-15
Marketing CategoryANDA / ANDA
Application NumberANDA079028
Labeler NameActavis Pharma, Inc.
Substance NameGALANTAMINE HYDROBROMIDE
Active Ingredient Strength16 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0591-3497-30

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0591-3497-30)
Marketing Start Date2008-12-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-3497-05 [00591349705]

Galantamine CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA079028
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-12-15
Marketing End Date2008-12-15

NDC 0591-3497-30 [00591349730]

Galantamine CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA079028
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-12-16

Drug Details

Active Ingredients

IngredientStrength
GALANTAMINE HYDROBROMIDE16 mg/1

OpenFDA Data

SPL SET ID:a074f2c6-fc31-4b04-80da-b905abe839b5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860695
  • 860707
  • 860715
  • Pharmacological Class

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

    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

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