NDC 68382-074

Finasteride

Finasteride

Finasteride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Finasteride.

Product ID68382-074_c8f04aaf-7ee2-4d41-92b2-072e9a500581
NDC68382-074
Product TypeHuman Prescription Drug
Proprietary NameFinasteride
Generic NameFinasteride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-12-05
Marketing CategoryANDA / ANDA
Application NumberANDA078900
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameFINASTERIDE
Active Ingredient Strength5 mg/1
Pharm Classes5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68382-074-01

100 TABLET, FILM COATED in 1 BOTTLE (68382-074-01)
Marketing Start Date2017-12-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-074-77 [68382007477]

Finasteride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078900
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-05

NDC 68382-074-06 [68382007406]

Finasteride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078900
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-05

NDC 68382-074-10 [68382007410]

Finasteride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078900
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-05

NDC 68382-074-01 [68382007401]

Finasteride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078900
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-05

NDC 68382-074-30 [68382007430]

Finasteride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078900
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-05
Marketing End Date2019-12-03

Drug Details

Active Ingredients

IngredientStrength
FINASTERIDE5 mg/1

OpenFDA Data

SPL SET ID:c3b1ea5f-5d84-4f6f-b1bb-0be087bd7768
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310346
  • Pharmacological Class

    • 5-alpha Reductase Inhibitor [EPC]
    • 5-alpha Reductase Inhibitors [MoA]

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

    NDCBrand NameGeneric Name
    0093-7355FinasterideFinasteride
    0179-0175FinasterideFinasteride
    0378-5036Finasteridefinasteride
    0904-6830FinasterideFinasteride
    16729-089FinasterideFinasteride
    16729-090Finasteridefinasteride
    17856-0090Finasteridefinasteride
    31722-525FinasterideFinasteride
    31722-526FinasterideFinasteride
    33261-833FinasterideFinasteride
    35573-400FinasterideFinasteride
    42291-280FinasterideFinasteride
    43598-303FinasterideFinasteride
    43598-390FinasterideFinasteride
    45963-500FinasterideFinasteride
    45963-600FINASTERIDEFINASTERIDE
    47335-714FinasterideFinasteride
    47335-715FINASTERIDEFINASTERIDE
    50090-1718Finasteridefinasteride
    67877-288FinasterideFinasteride
    67877-455FinasterideFinasteride
    68071-1648FinasterideFinasteride
    68071-1710FinasterideFinasteride
    68071-3234FinasterideFinasteride
    68071-3306FinasterideFinasteride
    68071-4044FinasterideFinasteride
    68071-3354FinasterideFinasteride
    68071-3380FinasterideFinasteride
    68071-4167FinasterideFinasteride
    68071-4541FinasterideFinasteride
    68071-4808FinasterideFinasteride
    68084-399FinasterideFinasteride
    68382-074FinasterideFinasteride
    68645-541FinasterideFinasteride
    68554-3026FinasterideFinasteride
    68554-3025FinasterideFinasteride
    68788-6976FinasterideFinasteride
    68788-6875FinasterideFinasteride
    68788-9519FinasterideFinasteride
    68788-9249FinasterideFinasteride
    68788-9517FinasterideFinasteride
    69097-112FinasterideFinasteride
    70518-0397FinasterideFinasteride
    70518-1704FinasterideFinasteride
    70771-1152FinasterideFinasteride
    71335-0433FinasterideFinasteride
    71335-0281FinasterideFinasteride
    71335-0235FinasterideFinasteride
    76282-412FinasterideFinasteride
    76519-1204FINASTERIDEFINASTERIDE

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