Losartan Potassium

Product NDC
68788-4007
11-digit product format
687884007
Labeler code
68788
Product ID
68788-4007_94eb89aa-296f-4e8f-a077-30a1be01ad52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA091497
Marketing category
ANDA
Marketing start
2025-08-08
Substance
LOSARTAN POTASSIUM
Active strength
25 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091497-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORALAB2011-06-06
A091497-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORALAB2011-06-06
A091497-003LOSARTAN POTASSIUMLOSARTAN POTASSIUM100MGTABLET / ORALAB2011-06-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091497-001AB
A091497-002AB
A091497-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091497-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2011-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091497-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2011-06-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091497-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2011-06-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091497-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2011-06-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091497-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2011-06-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091497-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2011-06-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A091497-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2011-06-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091497-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2011-06-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091497-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2011-06-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091497-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2011-06-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091497-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2011-06-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091497-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2011-06-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091497-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2011-06-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091497-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2011-06-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091497-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2011-06-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091497-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2011-06-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091497-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2011-06-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091497-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2011-06-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091497-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2011-06-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091497-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2011-06-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091497-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2011-06-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091497-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2011-06-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091497-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2011-06-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091497-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2011-06-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091497-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2011-06-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091497-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2011-06-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091497-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2011-06-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091497-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2011-06-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A091497-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2011-06-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A091497-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2011-06-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091497-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2011-06-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091497-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2011-06-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091497-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2011-06-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091497-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2011-06-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091497-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2011-06-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091497-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2011-06-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091497-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2011-06-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091497-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2011-06-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091497-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2011-06-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091497-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2011-06-068072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091497-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091497-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091497-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091497-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091497-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091497-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091497-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091497-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091497-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091497-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091497-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091497-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091497-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091497-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091497-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091497-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091497-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091497-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091497-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091497-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091497-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091497-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091497-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091497-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091497-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091497-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091497-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091497-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091497-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091497-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091497-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091497-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091497-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091497-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091497-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091497-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091497-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091497-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091497-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091497-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Losartan Potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOSARTAN POTASSIUM25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ST302B24AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
979485Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
94eb89aa-296f-4e8f-a077-30a1be01ad52Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0d341e63-aee5-498b-bf9a-b53a43963acfProduct name120260105
de29c5c0-90ba-29da-d7ab-0500274708beProduct name620241009
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-4007-1Losartan Potassium100 in 1 BOTTLETABLET, FILM COATED1001
68788-4007-3Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED301
68788-4007-5Losartan Potassium50 in 1 BOTTLETABLET, FILM COATED501
68788-4007-6Losartan Potassium60 in 1 BOTTLETABLET, FILM COATED601
68788-4007-9Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4007-1EA - Each68788-4007647a58d9-2cdc-4786-8d34-f8db10e152b912025-11-13
68788-4007-3EA - Each68788-4007d6662f3e-8506-42d7-9119-919b82a7304f12025-11-13
68788-4007-5EA - Each68788-40076084ba91-92d2-4ae4-a3c6-01680aadd1fd12025-11-13
68788-4007-6EA - Each68788-400724cb4633-bd72-4ff4-abdc-72ee8c451cd012025-11-13
68788-4007-9EA - Each68788-400734126766-4941-47e2-985e-3da4f121506d12025-11-13

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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan PotassiumLOSARTAN POTASSIUMUnit Dose Solutions, Inc.5529733c-1e3b-e590-e063-6294a90a765c2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497
Losartan PotassiumLOSARTAN POTASSIUMCoupler LLC53456224-db79-e7c1-e063-6394a90a90d52026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497
Losartan PotassiumLOSARTAN POTASSIUMPreferred Pharmaceuticals Inc.c4b81f90-bcd0-45d0-99ce-35ca998d473a2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.e136356b-e4d2-4e00-a409-35825c5637c92026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497
Losartan PotassiumLOSARTAN POTASSIUMSolco Healthcare US, LLCfa0cf2c2-6238-4edd-94e2-b670b98a0da42025-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497
Losartan PotassiumLOSARTAN POTASSIUMPreferred Pharmaceuticals Inc.94eb89aa-296f-4e8f-a077-30a1be01ad522025-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497
ndc (product): 68788-4007
Losartan PotassiumLOSARTAN POTASSIUMPreferred Pharmaceuticals Inc.68ed9727-987e-4bb6-98b4-b98150bb64042025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497
Losartan PotassiumLOSARTAN POTASSIUMNuCare Pharmaceuticals.Inc.351d3c5c-05c6-921a-e063-6394a90abef92025-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497
LOSARTAN POTASSIUMLOSARTAN POTASSIUMDIRECT RXa58c56b2-e05c-6697-e053-2a95a90ad4662025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497
Losartan PotassiumLOSARTAN POTASSIUMNuCare Pharmaceuticals,Inc.de5c0c87-e90b-fc14-e053-2a95a90af0c52024-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497
Losartan PotassiumLOSARTAN POTASSIUMBryant Ranch Prepack43fa4762-cc0c-4a3b-a527-6aa7fb7c54642024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497
Losartan PotassiumLOSARTAN POTASSIUMBryant Ranch Prepackde987691-f659-45ab-9c53-402ef7421f4b2024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497
Losartan PotassiumLOSARTAN POTASSIUMProficient Rx LP4b298291-4251-4af8-a436-58a3443a79782024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497
Losartan PotassiumLOSARTAN POTASSIUMNuCare Pharmaceuticals,iNc.54b363c4-00bb-08db-e054-00144ff8d46c2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497
Losartan PotassiumLOSARTAN POTASSIUMProficient Rx LPc0319153-3e35-4a84-aa63-935b1e0047d82022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497
Losartan PotassiumLOSARTAN POTASSIUMProficient Rx LP1b3c03e8-da8e-4c25-a493-118e760a003b2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497
Losartan PotassiumLOSARTAN POTASSIUMAphena Pharma Solutions - Tennessee, LLC35e3472a-457f-4f95-a78d-dbff2595171d2019-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497
Losartan PotassiumLOSARTAN POTASSIUMAphena Pharma Solutions - Tennessee, LLC1f55aaa2-5848-47e0-bba0-6a70b2fa05dd2018-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091497
application number: ANDA091497

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSN94eb89aa-296f-4e8f-a077-30a1be01ad521
979485losartan potassium 25 MG Oral TabletSCD94eb89aa-296f-4e8f-a077-30a1be01ad521
979485Losartan K+ 25 MG Oral TabletSY94eb89aa-296f-4e8f-a077-30a1be01ad521
979485Losartan Pot 25 MG Oral TabletSY94eb89aa-296f-4e8f-a077-30a1be01ad521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4007-168788400701100 TABLET, FILM COATED in 1 BOTTLE (68788-4007-1) 2025-08-08NoNoCurrent
68788-4007-36878840070330 TABLET, FILM COATED in 1 BOTTLE (68788-4007-3) 2025-08-08NoNoCurrent
68788-4007-56878840070550 TABLET, FILM COATED in 1 BOTTLE (68788-4007-5) 2025-08-08NoNoCurrent
68788-4007-66878840070660 TABLET, FILM COATED in 1 BOTTLE (68788-4007-6) 2025-08-08NoNoCurrent
68788-4007-96878840070990 TABLET, FILM COATED in 1 BOTTLE (68788-4007-9) 2025-08-08NoNoCurrent