NDC 65862-745

Galantamine

Galantamine

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

Product ID65862-745_1c1bcf71-4df7-4ddd-a79e-685317023bce
NDC65862-745
Product TypeHuman Prescription Drug
Proprietary NameGalantamine
Generic NameGalantamine
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-08-05
Marketing CategoryANDA / ANDA
Application NumberANDA204895
Labeler NameAurobindo Pharma Limited
Substance NameGALANTAMINE HYDROBROMIDE
Active Ingredient Strength16 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65862-745-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-745-01)
Marketing Start Date2016-08-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-745-99 [65862074599]

Galantamine CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204895
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-08-05

NDC 65862-745-05 [65862074505]

Galantamine CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204895
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-08-05

NDC 65862-745-90 [65862074590]

Galantamine CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204895
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-08-05

NDC 65862-745-01 [65862074501]

Galantamine CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204895
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-08-05

NDC 65862-745-30 [65862074530]

Galantamine CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204895
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-08-05

Drug Details

Active Ingredients

IngredientStrength
GALANTAMINE HYDROBROMIDE16 mg/1

OpenFDA Data

SPL SET ID:d0b75970-8d3d-408b-9e17-9cbad0f776b1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860695
  • 860707
  • 860715
  • UPC Code
  • 0365862744302
  • 0365862745309
  • 0365862746306
  • Pharmacological Class

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

    Medicade Reported Pricing

    65862074530 GALANTAMINE ER 16 MG CAPSULE

    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

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