Losartan Potassium

Product NDC
43063-954
11-digit product format
430630954
Labeler code
43063
Product ID
43063-954_3fa404aa-687c-d48c-e063-6394a90a9dc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090083
Marketing category
ANDA
Marketing start
2010-10-06
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
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Losartan Potassium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOSARTAN POTASSIUM100 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
979480Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9a92771-5c73-4f17-ac38-29fabfd4a919Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-954-30Losartan Potassium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-954-30EA - Each43063-954e982d80a-aaf1-4ec0-bd04-98522bbdc41712019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-954LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]26Current NDC, Legacy NDC, 1 package rows20240927_f9a92771-5c73-4f17-ac38-29fabfd4a919.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 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
ndc (product): 43063-954
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSNf9a92771-5c73-4f17-ac38-29fabfd4a91928
979480losartan potassium 100 MG Oral TabletSCDf9a92771-5c73-4f17-ac38-29fabfd4a91928
979480Losartan K+ 100 MG Oral TabletSYf9a92771-5c73-4f17-ac38-29fabfd4a91928
979480Losartan Pot 100 MG Oral TabletSYf9a92771-5c73-4f17-ac38-29fabfd4a91928

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-954-304306309543030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-954-30) 2019-03-060000-00-00NoNoCurrent