Losartan Potassium

Product NDC
68788-7664
11-digit product format
687887664
Labeler code
68788
Product ID
68788-7664_f168dcee-b30a-4fb4-b62b-631707d14c1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA203835
Marketing category
ANDA
Marketing start
2020-02-28
Marketing end
0000-00-00
Substance
LOSARTAN POTASSIUM
Active strength
100 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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-7664DDiscontinued by firm2026-08-17
excluded packagepackage68788-766468788-7664-1DDiscontinued by firm2026-08-17
excluded packagepackage68788-766468788-7664-3DDiscontinued by firm2026-08-17
excluded packagepackage68788-766468788-7664-6DDiscontinued by firm2026-08-17
excluded packagepackage68788-766468788-7664-9DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203835-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORALAB2015-08-12
A203835-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORALAB2015-08-12
A203835-003LOSARTAN POTASSIUMLOSARTAN POTASSIUM100MGTABLET / ORALAB2015-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203835-001AB
A203835-002AB
A203835-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203835-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2015-08-12caaa826d4ba7…
2026-08-18 06:07:402026-07A203835-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2015-08-12caaa826d4ba7…
2026-08-18 06:07:402026-07A203835-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2015-08-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203835-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2015-08-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203835-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2015-08-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203835-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2015-08-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203835-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2015-08-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203835-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2015-08-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203835-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2015-08-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A203835-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2015-08-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203835-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2015-08-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203835-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2015-08-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203835-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2015-08-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203835-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2015-08-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203835-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2015-08-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203835-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2015-08-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203835-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2015-08-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203835-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2015-08-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203835-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2015-08-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203835-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2015-08-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203835-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2015-08-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203835-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2015-08-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203835-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2015-08-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203835-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2015-08-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203835-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2015-08-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203835-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2015-08-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203835-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2015-08-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203835-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2015-08-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203835-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2015-08-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203835-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2015-08-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203835-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2015-08-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A203835-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2015-08-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A203835-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2015-08-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203835-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2015-08-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203835-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2015-08-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203835-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2015-08-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203835-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2015-08-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203835-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2015-08-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203835-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2015-08-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203835-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2015-08-121e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203835-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203835-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203835-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203835-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203835-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203835-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203835-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203835-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203835-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203835-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203835-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203835-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203835-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203835-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203835-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203835-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203835-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203835-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203835-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203835-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203835-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203835-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203835-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203835-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203835-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203835-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203835-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203835-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203835-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203835-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203835-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203835-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203835-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203835-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203835-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203835-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203835-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203835-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203835-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203835-001AB11e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7664-1EA - Each68788-76647770edc4-5f5a-4c56-bcd9-27d9406d615812020-05-08
68788-7664-3EA - Each68788-7664cfbb5bb6-d746-4488-9530-eb51a79046db12020-05-08
68788-7664-6EA - Each68788-76649794ade2-c178-4ea4-94db-f7409091c4e212020-05-08
68788-7664-9EA - Each68788-766457b2b511-28fc-4ee2-ae54-53f6b8d907f012020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7664LOSARTAN POTASSIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]5Legacy NDC20240629_7d71fc05-0d85-45d9-85e7-305df66d788f.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 3 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan PotassiumLOSARTAN POTASSIUMRedpharm Drug5833c02c-9957-a069-e063-6294a90ad3e42026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.6f39f7f9-edac-45ca-9ee2-c2ecad0915ab2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.1843ee4b-1afc-4992-993a-4b0e03e785fc2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.9b3ddaa2-a835-736a-e053-2995a90aff082026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.45c01cc9-c7d1-4bb6-a105-354fc936ec632026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMCoupler LLC53e82c07-fe4c-78db-e063-6394a90a80872026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMSt. Mary's Medical Park Pharmacyaaf943ff-d6af-8ce2-e053-2995a90a7b762026-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMBryant Ranch Prepack0f3a6984-e601-4a74-9910-49ee5e352d6b2026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMPreferred Pharmaceuticals, Inc.fe1df76d-4925-444d-8e30-9dd07f205fb72026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.abb56236-f2fe-45b5-93ac-35fd661f89922026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMA-S Medication Solutions23117ad8-39ad-44f2-b7d2-2dbc8edc97342026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMA-S Medication Solutionsd7b61f05-871d-4ffd-ab9b-9a3e60fd34c42026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMNuCare Pharmaceuticals,Inc.ba76eb91-bea6-4e37-e053-2a95a90a065a2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMA-S Medication Solutions3ee3240f-78a1-4fd2-a779-c226937117212026-02-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMA-S Medication Solutionsf29cc61a-afba-4ecb-8043-5f103872f1ae2026-02-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMA-S Medication Solutions2c810cde-fa40-4772-806e-c31809e6bbfb2026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMNorthwind Health Company, LLCd9df33c8-4ea7-5d1c-e053-2a95a90aecf72026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMQPharma, Inc.0c9f3e8c-eafb-4be4-aca5-1d5aa3d7d7382025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMQPharma, Inc.c80b36c2-fa22-e7a9-e053-2a95a90ae21e2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835
Losartan PotassiumLOSARTAN POTASSIUMQPharma, Inc.c80b3a28-ef15-5902-e053-2995a90a06d72025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7664-168788766401100 TABLET, FILM COATED in 1 BOTTLE (68788-7664-1) 2020-02-280000-00-00NoNoCurrent
68788-7664-36878876640330 TABLET, FILM COATED in 1 BOTTLE (68788-7664-3) 2020-02-280000-00-00NoNoCurrent
68788-7664-66878876640660 TABLET, FILM COATED in 1 BOTTLE (68788-7664-6) 2020-02-280000-00-00NoNoCurrent
68788-7664-96878876640990 TABLET, FILM COATED in 1 BOTTLE (68788-7664-9) 2020-02-280000-00-00NoNoCurrent