Label: TAMSULOSIN HYDROCHLORIDE capsule

  • NDC Code(s): 65841-695-01, 65841-695-05, 65841-695-06, 65841-695-10, view more
    65841-695-14, 65841-695-16, 65841-695-77
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 12, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

  • 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
  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!