Tamsulosin Hydrochloride (Page 6 of 6)

PRINCIPAL DISPLAY PANEL-Label

NDC 16714-713-02
Tamsulosin Hydrochloride Capsules, USP
0.4 mg
Rx only
500 Capsules
NORTHSTAR

tamsulosin-label
(click image for full-size original)

TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-713
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
MICROCRYSTALLINE CELLULOSE
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
HYPROMELLOSE ACETATE SUCCINATE 16070722 (3 MM2/S)
TRIETHYL CITRATE
TALC
SODIUM LAURYL SULFATE
GELATIN, UNSPECIFIED
FD&C BLUE NO. 2
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
Product Characteristics
Color GREEN (olive green) , YELLOW (light yellow) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 160
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-713-01 100 CAPSULE in 1 BOTTLE None
2 NDC:16714-713-02 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090931 05/01/2017
Labeler — NorthStar RxLLC (830546433)
Registrant — Sun Pharmaceutical Industries Limited (650172430)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 725959238 ANALYSIS (16714-713), MANUFACTURE (16714-713)

Revised: 02/2019 NorthStar RxLLC

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