NDC 70518-0397

Finasteride

Finasteride

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

Product ID70518-0397_8469d067-b6bc-58da-e053-2a91aa0a80ac
NDC70518-0397
Product TypeHuman Prescription Drug
Proprietary NameFinasteride
Generic NameFinasteride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-04-04
Marketing CategoryANDA / ANDA
Application NumberANDA090121
Labeler NameREMEDYREPACK 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 70518-0397-0

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0397-0)
Marketing Start Date2017-04-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0397-1 [70518039701]

Finasteride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090121
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-10

NDC 70518-0397-0 [70518039700]

Finasteride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090121
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-04

NDC 70518-0397-2 [70518039702]

Finasteride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090121
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-11

Drug Details

Active Ingredients

IngredientStrength
FINASTERIDE5 mg/1

OpenFDA Data

SPL SET ID:5fbbb583-5c89-4cf1-b952-261558a9afd1
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

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