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 
Vivimed Labs Limited

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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

HOW SUPPLIED

Losartan Potassium Tablets, USP are available as follows:

25 mg – Each white, round, biconvex film coated tablets debossed with "11" 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 "12" 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 "13"  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.

PACKAGE LABEL.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
LOSARTAN POTASSIUM  25 MG
losartan potassium tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62980-501
Route of AdministrationORAL
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 Product03/11/201411/26/2019
2NDC:62980-501-0290 in 1 BOTTLE; Type 0: Not a Combination Product03/11/201411/26/2019
3NDC:62980-501-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/11/201411/26/2019
4NDC:62980-501-031000 in 1 BOTTLE; Type 0: Not a Combination Product03/11/201411/26/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09038203/11/201411/26/2019
LOSARTAN POTASSIUM  50 MG
losartan potassium tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62980-502
Route of AdministrationORAL
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:62980-502-0290 in 1 BOTTLE; Type 0: Not a Combination Product03/11/201411/26/2019
2NDC:62980-502-0130 in 1 BOTTLE; Type 0: Not a Combination Product03/11/201411/26/2019
3NDC:62980-502-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/11/201411/26/2019
4NDC:62980-502-031000 in 1 BOTTLE; Type 0: Not a Combination Product03/11/201411/26/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09038203/11/201411/26/2019
LOSARTAN POTASSIUM  100 MG
losartan potassium tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62980-503
Route of AdministrationORAL
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:62980-503-0290 in 1 BOTTLE; Type 0: Not a Combination Product03/11/201411/26/2019
2NDC:62980-503-0130 in 1 BOTTLE; Type 0: Not a Combination Product03/11/201411/26/2019
3NDC:62980-503-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/11/201411/26/2019
4NDC:62980-503-031000 in 1 BOTTLE; Type 0: Not a Combination Product03/11/201411/26/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09038203/11/201411/26/2019
Labeler - Vivimed Labs Limited (650210664)
Establishment
NameAddressID/FEIBusiness Operations
Vivimed Life Sciences Private Limited860477684ANALYSIS(62980-501, 62980-502, 62980-503) , MANUFACTURE(62980-501, 62980-502, 62980-503)

Revised: 11/2019
Document Id: e7cffd03-edbb-40c5-bd64-6c570991592a
Set id: 9937ccb7-32bd-4fd4-81a0-bedad6810efe
Version: 7
Effective Time: 20191126
 
Vivimed Labs Limited