NDC 70518-2378

Dutasteride

Dutasteride

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

Product ID70518-2378_96283b0d-5303-6f5f-e053-2995a90aead4
NDC70518-2378
Product TypeHuman Prescription Drug
Proprietary NameDutasteride
Generic NameDutasteride
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2019-10-23
Marketing CategoryANDA / ANDA
Application NumberANDA206574
Labeler NameREMEDYREPACK INC.
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 70518-2378-2

30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70518-2378-2)
Marketing Start Date2020-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2378-0 [70518237800]

Dutasteride CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206574
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-23

NDC 70518-2378-1 [70518237801]

Dutasteride CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206574
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-23

NDC 70518-2378-2 [70518237802]

Dutasteride CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206574
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-03

Drug Details

Active Ingredients

IngredientStrength
DUTASTERIDE.5 mg/1

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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