NDC 68382-641

Dutasteride

Dutasteride

Dutasteride is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Dutasteride.

Product ID68382-641_791e9054-ec90-45b1-bd3e-7dbc689399ac
NDC68382-641
Product TypeHuman Prescription Drug
Proprietary NameDutasteride
Generic NameDutasteride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2018-05-16
Marketing CategoryANDA / ANDA
Application NumberANDA204373
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameDUTASTERIDE
Active Ingredient Strength1 mg/1
Pharm Classes5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68382-641-06

30 CAPSULE, LIQUID FILLED in 1 BOTTLE (68382-641-06)
Marketing Start Date2018-05-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-641-16 [68382064116]

Dutasteride CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA204373
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-16
Marketing End Date2019-04-26

NDC 68382-641-06 [68382064106]

Dutasteride CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA204373
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-16
Marketing End Date2019-04-26

Drug Details

Active Ingredients

IngredientStrength
DUTASTERIDE.5 mg/1

OpenFDA Data

SPL SET ID:3676ef86-3195-467d-818e-4f6420fedfb5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351172
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0054-0395DutasterideDutasteride
    0115-1438DutasterideDutasteride
    0591-2292DutasterideDutasteride
    25000-011DutasterideDutasteride
    31722-131DutasterideDutasteride
    42543-139DutasterideDutasteride
    42806-549DutasterideDutasteride
    50090-2285Dutasteridedutasteride
    50090-3040DutasterideDutasteride
    50090-4010DutasterideDutasteride
    50268-282DutasterideDutasteride
    51013-190DutasterideDutasteride
    51407-157DutasterideDutasteride
    51991-749DUTASTERIDEDUTASTERIDE
    53345-037DutasterideDutasteride
    60429-935Dutasteridedutasteride
    60505-3877Dutasteridedutasteride
    62112-8068Dutasteridedutasteride
    63187-657DutasterideDutasteride
    63629-1222DutasterideDutasteride
    63629-1223DutasterideDutasteride
    63629-8207DutasterideDutasteride
    64380-763DutasterideDutasteride
    64980-224DUTASTERIDEdutasteride
    68071-4237DutasterideDutasteride
    68071-4609DutasterideDutasteride
    68071-4607DutasterideDutasteride
    68071-4821DutasterideDutasteride
    68382-641DutasterideDutasteride
    70518-1966DutasterideDutasteride
    70771-1347DutasterideDutasteride
    71205-039DutasterideDutasteride
    65162-750DutasterideDutasteride
    72578-019DutasterideDutasteride
    71205-278DutasterideDutasteride
    70518-2256DutasterideDutasteride
    70518-2378DutasterideDutasteride
    72865-140DutasterideDutasteride
    0173-0712AVODARTdutasteride

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