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Losartan

Generic Name: Losartan potassium
Dosage Form: tablet

Medically reviewed on Dec 1, 2018

How Supplied/Storage and Handling

Losartan Potassium Tablets, USP are available as follows:

25 mg – Each white, round, biconvex film coated tablets debossed with  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   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  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.

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

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

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

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

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

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

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

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

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

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

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

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

Losartan POTASSIUM  25 MG
Losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62980-501
Route of Administration ORAL, ORAL, ORAL, ORAL, ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Losartan POTASSIUM (Losartan) Losartan POTASSIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
HYPROMELLOSES  
MAGNESIUM STEARATE  
MANNITOL  
CELLULOSE, MICROCRYSTALLINE  
POVIDONE  
PROPYLENE GLYCOL  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color white Score no score
Shape ROUND (Round, Biconvex) Size 8mm
Flavor Imprint Code 11
Contains     
Packaging
# Item Code Package Description
1 NDC:62980-501-01 30 TABLET, FILM COATED in 1 BOTTLE
2 NDC:62980-501-02 90 TABLET, FILM COATED in 1 BOTTLE
3 NDC:62980-501-05 500 TABLET, FILM COATED in 1 BOTTLE
4 NDC:62980-501-03 1000 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090382 03/11/2014
Losartan POTASSIUM  50 MG
Losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62980-502
Route of Administration ORAL, ORAL, ORAL, ORAL, ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Losartan POTASSIUM (Losartan) Losartan POTASSIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
HYPROMELLOSES  
MAGNESIUM STEARATE  
MANNITOL  
CELLULOSE, MICROCRYSTALLINE  
POVIDONE  
PROPYLENE GLYCOL  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color white Score 2 pieces
Shape ROUND (Round, Biconvex) Size 10mm
Flavor Imprint Code 12
Contains     
Packaging
# Item Code Package Description
1 NDC:62980-502-01 30 TABLET, FILM COATED in 1 BOTTLE
2 NDC:62980-502-02 90 TABLET, FILM COATED in 1 BOTTLE
3 NDC:62980-502-05 500 TABLET, FILM COATED in 1 BOTTLE
4 NDC:62980-502-03 1000 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090382 03/11/2014
Losartan POTASSIUM  100 MG
Losartan potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:62980-503
Route of Administration ORAL, ORAL, ORAL, ORAL, ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Losartan POTASSIUM (Losartan) Losartan POTASSIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
HYPROMELLOSES  
MAGNESIUM STEARATE  
MANNITOL  
CELLULOSE, MICROCRYSTALLINE  
POVIDONE  
PROPYLENE GLYCOL  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color white Score no score
Shape OVAL (Oval, Biconvex) Size 18mm
Flavor Imprint Code 13
Contains     
Packaging
# Item Code Package Description
1 NDC:62980-503-01 30 TABLET, FILM COATED in 1 BOTTLE
2 NDC:62980-503-02 90 TABLET, FILM COATED in 1 BOTTLE
3 NDC:62980-503-05 500 TABLET, FILM COATED in 1 BOTTLE
4 NDC:62980-503-03 1000 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090382 03/11/2014
Labeler - Vivimed Labs Limited (650210664)
Registrant - Strides Vivimed Pte. Ltd. (659263057)
Establishment
Name Address ID/FEI Operations
Vivimed Life Sciences Private Limited 860477684 manufacture(62980-501, 62980-502, 62980-503), analysis(62980-501, 62980-502, 62980-503), pack(62980-501, 62980-502, 62980-503)
 
Vivimed Labs Limited
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