LOSARTAN POTASSIUM

Product NDC
71335-1136
Requested package NDC
71335-1136-3
11-digit product format
713351136
Labeler code
71335
Product ID
71335-1136_844e9245-1cfa-400c-b2d5-93a5924290a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
losartan potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091541
Marketing category
ANDA
Marketing start
2012-12-06
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A091541-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-24
A091541-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-24
A091541-003LOSARTAN POTASSIUMLOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091541-001AB
A091541-002AB
A091541-003AB

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 UTC2026-02A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091541-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2012-09-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091541-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2012-09-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091541-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2012-09-248072bd15b7f6…

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 UTC2026-02A091541-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091541-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091541-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091541-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091541-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091541-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091541-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091541-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091541-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091541-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091541-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091541-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091541-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091541-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091541-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091541-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091541-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091541-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091541-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091541-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091541-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091541-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091541-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091541-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091541-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091541-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091541-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091541-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091541-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091541-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091541-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091541-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091541-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091541-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091541-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091541-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091541-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091541-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091541-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091541-001AB18072bd15b7f6…

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
eace2965-c02b-49ec-aad8-3a69a6ae9cbfAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71335-1136-12025-09-18These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995
71335-1136-22025-09-18These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995
71335-1136-32025-09-18These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995
71335-1136-42025-09-18These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995
71335-1136-52025-09-18These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995
71335-1136-12024-01-30These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995
71335-1136-22024-01-30These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995
71335-1136-32024-01-30These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995
71335-1136-42024-01-30These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995
71335-1136-52024-01-30These highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1136-1LOSARTAN POTASSIUM90 in 1 BOTTLETABLET, FILM COATED903
71335-1136-2LOSARTAN POTASSIUM30 in 1 BOTTLETABLET, FILM COATED303
71335-1136-3LOSARTAN POTASSIUM60 in 1 BOTTLETABLET, FILM COATED603
71335-1136-4LOSARTAN POTASSIUM100 in 1 BOTTLETABLET, FILM COATED1003
71335-1136-5LOSARTAN POTASSIUM10 in 1 BOTTLETABLET, FILM COATED103
71335-1136-6LOSARTAN POTASSIUM7 in 1 BOTTLETABLET, FILM COATED73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1136LOSARTAN POTASSIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2Current NDC, Legacy NDC, 6 package rows20220225_eace2965-c02b-49ec-aad8-3a69a6ae9cbf.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOSARTAN POTASSIUMLOSARTAN POTASSIUMBryant Ranch Prepackeace2965-c02b-49ec-aad8-3a69a6ae9cbf2025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091541
application number: ANDA091541
ndc (package): 71335-1136-3
ndc (product): 71335-1136
ndc11 (package): 71335113603
LOSARTAN POTASSIUMLOSARTAN POTASSIUMMicro Labs Limitedf2f2b6c6-0ab1-483f-b4a2-78dfe32001532025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091541
application number: ANDA091541

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSNeace2965-c02b-49ec-aad8-3a69a6ae9cbf3
979485losartan potassium 25 MG Oral TabletSCDeace2965-c02b-49ec-aad8-3a69a6ae9cbf3
979485Losartan K+ 25 MG Oral TabletSYeace2965-c02b-49ec-aad8-3a69a6ae9cbf3
979485Losartan Pot 25 MG Oral TabletSYeace2965-c02b-49ec-aad8-3a69a6ae9cbf3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1136-37133511360360 TABLET, FILM COATED in 1 BOTTLE (71335-1136-3) 2019-03-040000-00-00NoNoCurrent