DUTASTERIDE CAPSULE, LIQUID FILLED [GLAXOSMITHKLINE LLC]

DUTASTERIDE CAPSULE, LIQUID FILLED [GLAXOSMITHKLINE LLC]
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NDC	0173-7077-00
Set ID	3fdc827c-182f-435c-a576-ba90d452ec7e
Category	HUMAN PRESCRIPTION DRUG LABEL
Packager	GlaxoSmithKline LLC
Generic Name
Product Class	5-alpha Reductase Inhibitor
Product Number
Application Number

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Storage and Handling

Store at 15-25°C
PRINCIPAL DISPLAY PANEL

NDC 0173-7077-00

Dutasteride 0.5mg Capsules

Store at 15-25°C

Quantity 200 BLISTERS

INGREDIENTS AND APPEARANCE

DUTASTERIDE
dutasteride capsule, liquid filled

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0173-7077
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DUTASTERIDE (UNII: O0J6XJN02I) (DUTASTERIDE - UNII:O0J6XJN02I)	DUTASTERIDE	0.5 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL (soft gelatin capsule)	Size	19mm
Flavor		Imprint Code	GS;MUF
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0173-7077-00	20 in 1 CARTON	02/19/2015
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Export only		02/19/2015

Labeler - GlaxoSmithKline LLC (167380711)

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