Losartan Potassium

Product NDC
68071-3216
Requested package NDC
68071-3216-9
11-digit product format
680713216
Labeler code
68071
Product ID
68071-3216_e4cddf04-1226-42e1-e053-2a95a90afff4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA091497
Marketing category
ANDA
Marketing start
2014-07-30
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68071-321668071-3216-9DDiscontinued by firm2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
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…

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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3216-62020-10-12C16284748780-19d75b9cf-d2c5-f424-e053-dadaa90a57ceLOSARTAN POTASSIUM TABLETS, USP, for oral use
68071-3216-62020-01-31C16284748780-19d75b9cf-d2c5-f424-e053-dadaa90a57ceLOSARTAN POTASSIUM TABLETS, USP, for oral use

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-3216-96807132160990 TABLET, FILM COATED in 1 BOTTLE (68071-3216-9) 2017-05-090000-00-00NoNoCurrent