NDC 65841-756

Galantamine

Galantamine

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

Product ID65841-756_6ef0e163-f218-4693-b490-a4e863220942
NDC65841-756
Product TypeHuman Prescription Drug
Proprietary NameGalantamine
Generic NameGalantamine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-10-10
Marketing CategoryANDA / ANDA
Application NumberANDA078898
Labeler NameZydus Lifesciences Limited
Substance NameGALANTAMINE HYDROBROMIDE
Active Ingredient Strength8 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65841-756-01

100 TABLET, FILM COATED in 1 BOTTLE (65841-756-01)
Marketing Start Date2011-10-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65841-756-77 [65841075677]

Galantamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078898
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-10

NDC 65841-756-01 [65841075601]

Galantamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078898
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-10

NDC 65841-756-30 [65841075630]

Galantamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078898
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-10
Marketing End Date2019-12-03

NDC 65841-756-14 [65841075614]

Galantamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078898
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-10

NDC 65841-756-10 [65841075610]

Galantamine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078898
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-10-10

Drug Details

Active Ingredients

IngredientStrength
GALANTAMINE HYDROBROMIDE8 mg/1

OpenFDA Data

SPL SET ID:63bad97b-3df6-4e8f-b183-95f1e9801c8f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 579148
  • 310437
  • 310436
  • 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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