Losartan potassium

Product NDC
0781-5702
Requested package NDC
0781-5702-92
11-digit product format
007815702
Labeler code
0781
Product ID
0781-5702_e0b9eaef-95a8-42d5-8970-471d7f52e11f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
losartan potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA077424
Marketing category
ANDA
Marketing start
2010-10-06
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
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 packagepackage0781-57020781-5702-92DDiscontinued by firm2026-08-17

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 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
A077424-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06
A077424-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06
A077424-003LOSARTAN 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
A077424-001AB
A077424-002AB
A077424-003AB

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 06:07:402026-07A077424-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A077424-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A077424-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077424-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077424-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077424-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077424-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077424-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077424-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077424-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077424-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077424-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077424-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077424-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077424-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077424-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077424-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077424-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077424-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077424-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077424-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077424-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077424-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077424-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077424-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077424-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077424-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077424-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077424-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077424-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077424-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077424-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077424-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077424-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077424-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077424-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077424-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077424-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077424-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077424-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-061e350fbaab3a…

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 06:07:402026-07A077424-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077424-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077424-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077424-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077424-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077424-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077424-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077424-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077424-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077424-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077424-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077424-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077424-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077424-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077424-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077424-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077424-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077424-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077424-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077424-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077424-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077424-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077424-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077424-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077424-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077424-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077424-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077424-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077424-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077424-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077424-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077424-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077424-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077424-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077424-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077424-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077424-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077424-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077424-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077424-001AB11e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5702-10EA - Each0781-5702ccf2ac02-fe04-442f-adfe-c0ad991fa55e12012-07-24
0781-5702-31EA - Each0781-57024db27d82-70f7-4191-b09e-26d50dedc7a812012-07-24
0781-5702-92EA - Each0781-57028cb2fa6a-ee11-4506-98d9-86af78f4b7d112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LOSARTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LOSARTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLOSARTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOSARTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLOSARTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
TALCINACTIVE INGREDIENT7SEV7J4R1ULOSARTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMLOSARTAN POTASSIUM (LOSARTAN POTASSIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC]8
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC]8
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC]8
TALCINACTIVE INGREDIENT7SEV7J4R1ULOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC]8
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMLOSARTAN POTASSIUM TABLET, FILM COATED [SANDOZ INC]8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-5702-920078157029290 TABLET, FILM COATED in 1 BOTTLE (0781-5702-92) 2010-10-060000-00-00NoNoCurrent