NDC Code(s) : 51013-190-30, 51013-190-09
Packager : PuraCap Pharmaceutical LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DutasterideDutasteride CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51013-190
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DUTASTERIDE(UNII: O0J6XJN02I)
(DUTASTERIDE - UNII:O0J6XJN02I) 		DUTASTERIDE0.5 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA(UNII: 5138Q19F1X)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES(UNII: U72Q2I8C85)
DIMETHICONE(UNII: 92RU3N3Y1O)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GELATIN(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color YELLOW (opaque) Score no score
Shape CAPSULE (oblong) Size 19 mm
Flavor Imprint Code PC23
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51013-190-3030 in 1 BOTTLE Type 0: Not a Combination Product29/05/2018
2NDC:51013-190-0990 in 1 BOTTLE Type 0: Not a Combination Product29/05/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209909 05/29/2018

LABELER - PuraCap Pharmaceutical LLC(962106329)

REGISTRANT - Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd(421293287)

Establishment
Name Address ID/FEI Business Operations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd 421293287 MANUFACTURE(51013-190)

PRINCIPAL DISPLAY PANEL

Dutasteride Capsules 0.5 mg

WARNING: Dutasteride capsules should not be used by women or children. Women who are or may potentially be pregnant should not use or handle dutasteride capsules (see prescribing information). If contact is made with leaking capsules, wash immediately with soap and water.

Rx Only

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