Label: LOSARTAN POTASSIUM 25 MG- losartan potassium tablet, film coated
LOSARTAN POTASSIUM 50 MG- losartan potassium tablet, film coated
LOSARTAN POTASSIUM 100 MG- losartan potassium tablet, film coated

  • NDC Code(s): 62980-501-01, 62980-501-02, 62980-501-03, 62980-501-05, view more
    62980-502-01, 62980-502-02, 62980-502-03, 62980-502-05, 62980-503-01, 62980-503-02, 62980-503-03, 62980-503-05
  • Packager: Vivimed Labs Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 11, 2018

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

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Losartan Potassium Tablets, USP are available as follows:

    25 mg – Each white, round, biconvex film coated tablets debossed with image01 on one side and plain on other side contains 25 mg of losartan potassium, USP. Tablets are supplied in bottles of 30 (NDC 62980-501-01), 90 (NDC 62980-501-02), 1000 (NDC 62980-501-03), and 10 x 10 (unit-dose tablets) (NDC 62980-501-04).

    50 mg – Each white, round, biconvex, film coated tablets debossed with image02  on scoreline side and plain on other side contains 50 mg of losartan potassium, USP. Tablets are supplied in bottles of 30 (NDC 62980-502-01), 90 (NDC 62980-502-02), 1000 (NDC 62980-502-03), and 10 x 10 (unit-dose tablets) (NDC 62980-502-04).

    100 mg – Each white, oval, biconvex film coated tablets debossed with image03 on one side and plain on other side contains 100 mg of losartan potassium, USP. Tablets are supplied in bottles of 30 (NDC 62980-503-01), 90 (NDC 62980-503-02), 1000 (NDC 62980-503-03), and 10 x 10 (unit-dose tablets) (NDC 62980-503-04).

    Storage
    Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature]. Keep container
    tightly closed. Protect from light.

    Dispense in a tight, light-resistant container as defined in USP.

  • PRINCIPAL DISPLAY PANEL

    NDC 62980-501-01

    Losartan Potassium Tablets, USP

    25 mg

    PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

    Rx Only

    30 film coated tablets

    Vivimed

    image04

    NDC 62980-501-02

    Losartan Potassium Tablets, USP

    25 mg

    PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

    Rx Only

    90 film coated tablets

    Vivimed

    image05

    NDC 62980-501-05

    Losartan Potassium Tablets, USP

    25 mg

    PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

    Rx Only

    500 film coated tablets

    Vivimed

    image06

    NDC 62980-501-03

    Losartan Potassium Tablets, USP

    25 mg

    PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

    Rx Only

    1000 film coated tablets

    Vivimed

    image07

    NDC 62980-502-01

    Losartan Potassium Tablets, USP

    50 mg

    PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

    Rx Only

    30 film coated tablets

    Vivimed

    image08

    NDC 62980-502-02

    Losartan Potassium Tablets, USP

    50 mg

    PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

    Rx Only

    90 film coated tablets

    Vivimed

    image09

    NDC 62980-502-05

    Losartan Potassium Tablets, USP

    50 mg

    PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

    Rx Only

    500 film coated tablets

    Vivimed

    image10

    NDC 62980-502-03

    Losartan Potassium Tablets, USP

    50 mg

    PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

    Rx Only

    1000 film coated tablets

    Vivimed

    image11

    NDC 62980-503-01

    Losartan Potassium Tablets, USP

    100 mg

    PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

    Rx Only

    30 film coated tablets

    Vivimed

    image12

    NDC 62980-503-02

    Losartan Potassium Tablets, USP

    100 mg

    PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

    Rx Only

    90 film coated tablets

    Vivimed

    image13

    NDC 62980-503-05

    Losartan Potassium Tablets, USP

    100 mg

    PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

    Rx Only

    500 film coated tablets

    Vivimed

    image14

    NDC 62980-503-03

    Losartan Potassium Tablets, USP

    100 mg

    PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.

    Rx Only

    1000 film coated tablets

    Vivimed

    image15

  • INGREDIENTS AND APPEARANCE
    LOSARTAN POTASSIUM  25 MG
    losartan potassium tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62980-501
    Route of AdministrationORAL, ORAL, ORAL, ORAL, ORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (Round, Biconvex) Size8mm
    FlavorImprint Code 11
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62980-501-0130 in 1 BOTTLE; Type 0: Not a Combination Product03/11/2014
    2NDC:62980-501-0290 in 1 BOTTLE; Type 0: Not a Combination Product03/11/2014
    3NDC:62980-501-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/11/2014
    4NDC:62980-501-031000 in 1 BOTTLE; Type 0: Not a Combination Product03/11/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09038203/11/2014
    LOSARTAN POTASSIUM  50 MG
    losartan potassium tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62980-502
    Route of AdministrationORAL, ORAL, ORAL, ORAL, ORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUND (Round, Biconvex) Size10mm
    FlavorImprint Code 12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62980-502-0130 in 1 BOTTLE; Type 0: Not a Combination Product03/11/2014
    2NDC:62980-502-0290 in 1 BOTTLE; Type 0: Not a Combination Product03/11/2014
    3NDC:62980-502-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/11/2014
    4NDC:62980-502-031000 in 1 BOTTLE; Type 0: Not a Combination Product03/11/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09038203/11/2014
    LOSARTAN POTASSIUM  100 MG
    losartan potassium tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62980-503
    Route of AdministrationORAL, ORAL, ORAL, ORAL, ORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89) LOSARTAN POTASSIUM100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL (Oval, Biconvex) Size18mm
    FlavorImprint Code 13
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62980-503-0130 in 1 BOTTLE; Type 0: Not a Combination Product03/11/2014
    2NDC:62980-503-0290 in 1 BOTTLE; Type 0: Not a Combination Product03/11/2014
    3NDC:62980-503-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/11/2014
    4NDC:62980-503-031000 in 1 BOTTLE; Type 0: Not a Combination Product03/11/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09038203/11/2014
    Labeler - Vivimed Labs Limited (650210664)
    Registrant - Strides Vivimed Pte. Ltd. (659263057)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vivimed Life Sciences Private Limited860477684manufacture(62980-501, 62980-502, 62980-503) , analysis(62980-501, 62980-502, 62980-503) , pack(62980-501, 62980-502, 62980-503)