TAMSULOSIN HYDROCHLORIDE - tamsulosin hydrochloride capsule 
Zydus Lifesciences Limited

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TAMSULOSIN HYDROCHLORIDE CAPSULES, USP

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
TAMSULOSIN HYDROCHLORIDE 
tamsulosin hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-695
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TAMSULOSIN HYDROCHLORIDE (UNII: 11SV1951MR) (TAMSULOSIN - UNII:G3P28OML5I) TAMSULOSIN HYDROCHLORIDE0.4 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
GELATIN (UNII: 2G86QN327L)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorGREEN (GREEN) , ORANGE (PEACH) Scoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint Code ZA;18;0;4mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-695-0630 in 1 BOTTLE; Type 0: Not a Combination Product04/27/2010
2NDC:65841-695-1460 in 1 BOTTLE; Type 0: Not a Combination Product04/27/2010
3NDC:65841-695-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/27/2010
4NDC:65841-695-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/27/2010
5NDC:65841-695-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/27/2010
6NDC:65841-695-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/27/2010
7NDC:65841-695-7710 in 1 CARTON04/27/2010
710 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07822504/27/2010
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-695) , MANUFACTURE(65841-695)

Revised: 10/2022
Document Id: 5878fa0c-ddc2-4783-9a3b-1b2a8f56fb92
Set id: 276c7e26-f86a-46b9-b626-ceef76b729a4
Version: 8
Effective Time: 20221031
 
Zydus Lifesciences Limited