Losartan Potassium

Product NDC
71610-207
11-digit product format
716100207
Labeler code
71610
Product ID
71610-207_efa818c7-3f30-4f41-9071-71e298ae171d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA091497
Marketing category
ANDA
Marketing start
2014-07-30
Substance
LOSARTAN POTASSIUM
Active strength
50 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 POTASSIUM50 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
979492Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1f55aaa2-5848-47e0-bba0-6a70b2fa05ddAvailable 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
71610-207-30Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED301
71610-207-45Losartan Potassium45 in 1 BOTTLETABLET, FILM COATED451
71610-207-60Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-207-30EA - Each71610-20743a7806c-2856-4e1a-a3f3-7c16586f9c3712019-05-02
71610-207-45EA - Each71610-207cf44d278-412d-4a24-9e20-fa96fade4eed12019-05-02
71610-207-60EA - Each71610-2078108c48b-dba8-4006-bfb5-6f3d07c2504512019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-207LOSARTAN POTASSIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 3 package rows20181227_1f55aaa2-5848-47e0-bba0-6a70b2fa05dd.zip

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
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
ndc (product): 71610-207

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979492losartan potassium 50 MG Oral TabletPSN1f55aaa2-5848-47e0-bba0-6a70b2fa05dd1
979492losartan potassium 50 MG Oral TabletSCD1f55aaa2-5848-47e0-bba0-6a70b2fa05dd1
979492Losartan K+ 50 MG Oral TabletSY1f55aaa2-5848-47e0-bba0-6a70b2fa05dd1
979492Losartan Pot 50 MG Oral TabletSY1f55aaa2-5848-47e0-bba0-6a70b2fa05dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-207-307161002073030 TABLET, FILM COATED in 1 BOTTLE (71610-207-30) 2018-12-140000-00-00NoNoCurrent
71610-207-457161002074545 TABLET, FILM COATED in 1 BOTTLE (71610-207-45) 2018-12-140000-00-00NoNoCurrent
71610-207-607161002076090 TABLET, FILM COATED in 1 BOTTLE (71610-207-60) 2018-12-140000-00-00NoNoCurrent