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NDC 63629-8207-01 Dutasteride 0.5 mg/1 Details

Dutasteride 0.5 mg/1

Dutasteride is a ORAL CAPSULE, LIQUID FILLED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is DUTASTERIDE.

MedlinePlus Drug Summary

Dutasteride is used alone or with another medication (tamsulosin [Flomax]) to treat benign prostatic hyperplasia (BPH; enlargement of the prostate gland). Dutasteride is used to treat symptoms of BPH and may reduce the chance of developing acute urinary retention (sudden inability to urinate). Dutasteride may also decrease the chance that prostate surgery will be needed. Dutasteride is in a class of medications called 5-alpha reductase inhibitors. It works by blocking the production of a natural substance that enlarges the prostate.

Related Packages: 63629-8207-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dutasteride

Product Information

NDC	63629-8207
Product ID	63629-8207_32a859eb-81da-4a95-9605-8156f75b5e36
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Dutasteride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dutasteride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	0.5
Active Ingredient Units	mg/1
Substance Name	DUTASTERIDE
Labeler Name	Bryant Ranch Prepack
Pharmaceutical Class	5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA206574
Listing Certified Through	2024-12-31

Package

NDC 63629-8207-01 (63629820701)

Pricing Information	N/A
NDC Package Code	63629-8207-1
Billing NDC	63629820701
Package	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-8207-1)
Marketing Start Date	2019-08-01
NDC Exclude Flag	N