Label: PERINDOPRIL ERBUMINE - perindopril erbumine tablet

  • NDC Code(s): 65862-286-53, 65862-287-19, 65862-288-59
  • Packager: Aurobindo Pharma Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated October 16, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION


    Perindopril Erbumine Tablets

    Close
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Bulk Tablet Label


    12000 Tablets

    Batch      :

    Mfg         :

    Expiry      :

    To be repacked within six months from the date of manufacturing

    NDC 65862-286-53

    BULK SHIPMENT

    PLEASE HANDLE CAREFULLY

    Rx only


    Perindopril Erbumine Tablets 2 mg


    Each tablet contains:
    Perindopril erbumine 2 mg.

    CAUTION:
    FOR REPACKAGING ONLY

    Store at
     20º to 25ºC (68º to 77ºF); excursions permitted to
    15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].

    Manufactured by:
    Aurobindo Pharma Limited
    Hyderabad-500 072, India



    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Bulk Tablet Label
    Close
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 mg Bulk Tablet Label



    10000 Tablets  
    Batch      :

    Mfg         :

    Expiry      :

    To be repacked within six months from the date of manufacturing

    NDC 65862-287-19

    BULK SHIPMENT
    PLEASE HANDLE CAREFULLY
     
    Rx only

    Perindopril Erbumine Tablets 4 mg

    Each tablet contains: Perindopril erbumine 4 mg.

    CAUTION: FOR REPACKAGING ONLY

    Store at 20º to 25ºC (68º to 77ºF); excursions permitted to
    15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].

    Manufactured by:
    Aurobindo Pharma Limited


    Hyderabad-500 072, India



    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 mg Bulk Tablet Label
    Close
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 mg Bulk Tablet Label


    5000 Tablets

    Batch      :

    Mfg         :

    Expiry      :

    To be repacked within six months from the date of manufacturing

    NDC 65862-288-59

    BULK SHIPMENT

    PLEASE HANDLE CAREFULLY

    Rx only


    Perindopril Erbumine Tablets 8 mg


    Each tablet contains:
    Perindopril erbumine 8 mg.

    CAUTION:
    FOR REPACKAGING ONLY

    Store at
    20º to 25ºC (68º to 77ºF); excursions permitted to
    15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].

    Manufactured by:
    Aurobindo Pharma Limited
    Hyderabad-500 072, India



    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 mg Bulk Tablet Label
    Close
  • INGREDIENTS AND APPEARANCE
    PERINDOPRIL ERBUMINE 
    perindopril erbumine tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-286
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PERINDOPRIL ERBUMINE (UNII: 1964X464OJ) (PERINDOPRILAT - UNII:2UV6ZNQ92K) PERINDOPRIL ERBUMINE 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color WHITE (White to Off-white) Score 2 pieces
    Shape ROUND (Biconvex) Size 5mm
    Flavor Imprint Code D;5;7
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65862-286-53 12000 in 1 BAG; Type 0: Not a Combination Product 11/10/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079070 11/10/2009
    PERINDOPRIL ERBUMINE 
    perindopril erbumine tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-287
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PERINDOPRIL ERBUMINE (UNII: 1964X464OJ) (PERINDOPRILAT - UNII:2UV6ZNQ92K) PERINDOPRIL ERBUMINE 4 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color WHITE (White to Off-white) Score 2 pieces
    Shape CAPSULE Size 8mm
    Flavor Imprint Code D;5;8
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65862-287-19 10000 in 1 BAG; Type 0: Not a Combination Product 11/10/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079070 11/10/2009
    PERINDOPRIL ERBUMINE 
    perindopril erbumine tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-288
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PERINDOPRIL ERBUMINE (UNII: 1964X464OJ) (PERINDOPRILAT - UNII:2UV6ZNQ92K) PERINDOPRIL ERBUMINE 8 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Color WHITE (White to Off-white) Score 2 pieces
    Shape ROUND (Biconvex) Size 8mm
    Flavor Imprint Code D;5;9
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65862-288-59 5000 in 1 BAG; Type 0: Not a Combination Product 11/10/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079070 11/10/2009
    Labeler - Aurobindo Pharma Limited (650082092)
    Establishment
    Name Address ID/FEI Business Operations
    Aurobindo Pharma Limited 918917642 ANALYSIS(65862-286, 65862-287, 65862-288) , MANUFACTURE(65862-286, 65862-287, 65862-288)
    Establishment
    Name Address ID/FEI Business Operations
    Aurobindo Pharma Limited 918917647 API MANUFACTURE(65862-286, 65862-287, 65862-288)
    Close