Tamsulosin Hydrochloride (Page 6 of 6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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TAMSULOSIN HYDROCHLORIDE
tamsulosin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-159(NDC:0228-2996)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN) TAMSULOSIN HYDROCHLORIDE 0.4 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
WATER
TALC
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
FD&C BLUE NO. 2
GELATIN
FERRIC OXIDE RED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
SHELLAC
Product Characteristics
Color ORANGE, GREEN (olive colored cap) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code TSL;0;4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53217-159-07 7 CAPSULE in 1 BOTTLE None
2 NDC:53217-159-30 30 CAPSULE in 1 BOTTLE None
3 NDC:53217-159-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078801 04/27/2010
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 02/2017 Aidarex Pharmaceuticals LLC

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