Prescription Drug Information: Tamsulosin Hydrochloride

TAMSULOSIN HYDROCHLORIDE — tamsulosin hydrochloride capsule
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-695-01 in bottle of 100 Capsules

Tamsulosin Hydrochloride Capsules USP, 0.4 mg

Rx only

100 Capsules

tamsulosin hcl capsules, 0.4 mg
(click image for full-size original)
TAMSULOSIN HYDROCHLORIDE
tamsulosin hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-695
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
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
FERRIC OXIDE YELLOW
METHACRYLIC ACID
POLYSORBATE 80
GELATIN
TALC
TITANIUM DIOXIDE
TRIACETIN
FERROSOFERRIC OXIDE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color GREEN (GREEN) , ORANGE (PEACH) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code ZA;18;0;4mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-695-06 30 CAPSULE in 1 BOTTLE None
2 NDC:65841-695-14 60 CAPSULE in 1 BOTTLE None
3 NDC:65841-695-16 90 CAPSULE in 1 BOTTLE None
4 NDC:65841-695-01 100 CAPSULE in 1 BOTTLE None
5 NDC:65841-695-05 500 CAPSULE in 1 BOTTLE None
6 NDC:65841-695-10 1000 CAPSULE in 1 BOTTLE None
7 NDC:65841-695-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
7 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (65841-695-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078225 04/27/2010
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 918596198 ANALYSIS (65841-695), MANUFACTURE (65841-695)

Revised: 10/2022 Zydus Lifesciences Limited

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