NDC 71205-278

Dutasteride

Dutasteride

Dutasteride is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Dutasteride.

Product ID71205-278_0645f639-fde7-4e00-8ecd-c73ba34f91d6
NDC71205-278
Product TypeHuman Prescription Drug
Proprietary NameDutasteride
Generic NameDutasteride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2016-10-24
Marketing CategoryANDA / ANDA
Application NumberANDA206574
Labeler NameProficient Rx LP
Substance NameDUTASTERIDE
Active Ingredient Strength1 mg/1
Pharm Classes5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71205-278-30

30 CAPSULE, LIQUID FILLED in 1 BOTTLE (71205-278-30)
Marketing Start Date2019-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71205-278-30 [71205027830]

Dutasteride CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206574
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-01

NDC 71205-278-60 [71205027860]

Dutasteride CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206574
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-01

NDC 71205-278-90 [71205027890]

Dutasteride CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206574
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-01

Drug Details

Active Ingredients

IngredientStrength
DUTASTERIDE.5 mg/1

OpenFDA Data

SPL SET ID:908832b2-21d6-48ae-89cb-f06687321f74
Manufacturer
UNII

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

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