Losartan Potassium

Product NDC
60760-125
Requested package NDC
60760-125-90
11-digit product format
607600125
Labeler code
60760
Product ID
60760-125_889091bd-1aec-f5bf-e053-2a95a90a999c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA090083
Marketing category
ANDA
Marketing start
2019-02-27
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
2020-12-31
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 packagepackage60760-12560760-125-90DDiscontinued by firm2026-08-07

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
A090083-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06
A090083-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06
A090083-003LOSARTAN 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
A090083-001AB
A090083-002AB
A090083-003AB

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 UTC2026-02A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-068072bd15b7f6…

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 UTC2026-02A090083-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090083-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090083-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090083-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090083-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090083-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090083-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090083-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090083-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090083-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090083-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090083-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090083-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090083-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090083-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090083-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090083-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090083-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090083-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090083-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090083-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090083-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090083-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090083-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090083-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090083-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090083-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090083-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090083-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090083-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090083-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090083-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090083-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090083-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090083-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090083-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090083-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090083-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090083-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090083-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-125-30EA - Each60760-12599b844fb-9f1f-4838-8c5a-27f310288f0112019-04-11
60760-125-90EA - Each60760-12529a7cfce-7464-45b0-a1e1-84081a74e81412019-04-11

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.df4f55f0-fb11-4f6f-a7ed-127b50f955fc2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.f7cf8a7d-90f1-46a3-abff-1eb316aa7d722026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.25c93638-7016-47d2-a57c-e4a5245ca41b2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMUnit Dose Solutions, Inc.552a2f78-6318-310f-e063-6394a90abb152026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.41069514-0491-41fe-b7fe-a52d42d338482026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.f9a92771-5c73-4f17-ac38-29fabfd4a9192026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.5f7612dc-dccf-49e2-b541-3dab9dc1f97a2026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMNorthwind Health Company, LLCd9ced981-d791-6600-e053-2995a90ace3b2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMNorthwind Health Company, LLCd9de3627-9aa2-65c8-e053-2995a90ab5ec2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMNorthwind Health Company, LLCd9dfae69-9ce7-0c6b-e053-2a95a90aace82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMQPharma, Inc.2a7513c4-b73b-46fe-ba86-6e58658cdbc72025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMQPharma, Inc.16a6a582-eb4d-41bc-9d49-fc1d4117b29a2025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMAurobindo Pharma Limited31366b4b-dfd6-4fda-babe-2cb3d2c14a2b2025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMBryant Ranch Prepack4d7a0e82-4791-4e3f-932a-2f1a2993ba362025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMBryant Ranch Prepack45d0b1cc-d88d-4044-9692-c143cdf7a1b82025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMBryant Ranch Prepack0c728db3-86ae-4ed9-b86a-78ff8d18876a2025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMA-S Medication Solutions73bb1210-fa46-4c88-b07c-14ff5580ef182025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMNuCare Pharmaceuticals,Inc.9130921b-02f0-82d6-e053-2995a90a9c0a2024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMNuCare Pharmaceuticals,Inc.91305ca4-7d56-2052-e053-2995a90a5d612024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMNuCare Pharmaceuticals,Inc.8c2b3412-254b-8fa9-e053-2a95a90a7dc62024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-125-906076001259090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-125-90) 2019-02-270000-00-00NoNoCurrent