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: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 14, 2020

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  • 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 - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-695) , MANUFACTURE(65841-695)