apsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0809
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DUTASTERIDE (DUTASTERIDE) DUTASTERIDE 0.5mg
TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN) TAMSULOSIN HYDROCHLORIDE 0.4mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES
FERRIC OXIDE YELLOW
GELATIN
GLYCERIN
TITANIUM DIOXIDE
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
CELLULOSE, MICROCRYSTALLINE
TALC
TRIETHYL CITRATE
CARRAGEENAN
FD&C YELLOW NO. 6
HYPROMELLOSES
FERRIC OXIDE RED
POTASSIUM CHLORIDE
TITANIUM DIOXIDE
Product Characteristics
Color BROWN (brown body and a orange cap) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code GZ;7CZ
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0173-0809-13 30 CAPSULE ( CAPSULE) in 1 BOTTLE None
2 NDC:0173-0809-59 90 CAPSULE ( CAPSULE) in 1 BOTTLE None
3 NDC:0173-0809-61 7 CAPSULE ( CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022460 06/21/2010
Labeler -GlaxoSmithKline LLC (167380711)
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