FDA.reportPublic FDA data

LOSARTAN POTASSIUM

Manufacturer
Vivimed Labs Limited | Strides Vivimed Pte. Ltd. | Vivimed Life Sciences Private Limited
Effective date
2018-12-11
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 00:39:24

Label at a glance#

ProductLOSARTAN POTASSIUM 25 mg
Active ingredientLOSARTAN POTASSIUM
Label structure2 sections

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 ta...

Label contents#

Full prescribing information#

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Losartan Potassium Tablets, USP are available as follows:

25 mg – Each white, round, biconvex film coated tablets debossed with image01image01 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 image02image02  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 image03image03 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

image04image04

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

image05image05

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

image06image06

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

image07image07

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

image08image08

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

image09image09

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

image10image10

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

image11image11

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

image12image12

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

image13image13

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

image14image14

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

image15image15

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62980-50162980-501-01, 62980-501-02, 62980-501-05, 62980-501-03
62980-50262980-502-01, 62980-502-02, 62980-502-05, 62980-502-03
62980-50362980-503-01, 62980-503-02, 62980-503-05, 62980-503-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
LOSARTAN POTASSIUM3ST302B24AACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
LOSARTAN POTASSIUM3ST302B24AACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
LOSARTAN POTASSIUM3ST302B24AACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090382-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06
A090382-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06
A090382-003LOSARTAN POTASSIUMLOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090382-001AB
A090382-002AB
A090382-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06c2088c7a36db…
2026-10-15 13:18:302026-09A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06c2088c7a36db…
2026-10-15 13:18:302026-09A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06c2088c7a36db…
2026-09-14 22:38:342026-08A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0684e616aacf4f…
2026-08-18 06:07:402026-07A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090382-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090382-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090382-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0679d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A090382-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A090382-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A090382-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A090382-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090382-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090382-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A090382-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090382-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090382-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090382-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090382-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090382-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090382-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090382-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090382-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090382-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090382-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090382-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090382-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090382-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090382-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090382-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090382-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090382-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090382-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090382-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090382-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090382-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090382-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090382-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090382-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090382-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090382-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090382-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090382-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090382-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090382-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090382-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090382-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090382-001AB179d66fd596c7…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e7cffd03-edbb-40c5-bd64-6c570991592a9937ccb7-32bd-4fd4-81a0-bedad6810efe2019-11-26Exact identifier
spl set id: 9937ccb7-32bd-4fd4-81a0-bedad6810efe

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.