Tamsulosin Hydrochloride (Page 6 of 6)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.4 mg (100 Capsules Bottle)

NDC 65862-598-01
Rx only
Tamsulosin Hydrochloride
Capsules, USP
0.4 mg AUROBINDO 100 Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 0.4 mg (100 Capsules Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.4 mg Blister Carton (3 x 10 Unit-dose)

NDC 65862-598-10 Rx only
Tamsulosin Hydrochloride
Capsules, USP
0.4 mg
AUROBINDO 30 (3 x 10 Unit-dose) Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 0.4 mg Blister Carton (3 x 10 Unit-dose)
(click image for full-size original)
TAMSULOSIN HYDROCHLORIDE tamsulosin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-598
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
CALCIUM STEARATE
FD&C BLUE NO. 2
GELATIN, UNSPECIFIED
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MICROCRYSTALLINE CELLULOSE
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
SODIUM LAURYL SULFATE
TALC
TRIACETIN
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
Product Characteristics
Color GREEN (Olive Green Opaque) , ORANGE (Orange Opaque) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code D;53
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-598-01 100 CAPSULE in 1 BOTTLE None
2 NDC:65862-598-05 500 CAPSULE in 1 BOTTLE None
3 NDC:65862-598-10 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (65862-598-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202433 04/30/2013
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-598), MANUFACTURE (65862-598)

Revised: 09/2021 Aurobindo Pharma Limited

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