Losartan potassium

Product NDC
67046-1470
Requested package NDC
67046-1470-3
11-digit product format
670461470
Labeler code
67046
Product ID
67046-1470_2d55243e-d784-601f-e063-6394a90ab498
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA217396
Marketing category
ANDA
Marketing start
2025-02-04
Substance
LOSARTAN POTASSIUM
Active strength
25 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 43.

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
A217396-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORALAB2023-08-14
A217396-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORALAB2023-08-14
A217396-003LOSARTAN POTASSIUMLOSARTAN POTASSIUM100MGTABLET / ORALAB2023-08-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217396-001AB
A217396-002AB
A217396-003AB

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 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217396-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2023-08-1484e616aacf4f…
2026-09-14 22:38:342026-08A217396-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2023-08-1484e616aacf4f…
2026-09-14 22:38:342026-08A217396-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2023-08-1484e616aacf4f…
2026-08-18 06:07:402026-07A217396-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2023-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07A217396-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2023-08-14caaa826d4ba7…
2026-08-18 06:07:402026-07A217396-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2023-08-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217396-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2023-08-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217396-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2023-08-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217396-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2023-08-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217396-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2023-08-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217396-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2023-08-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217396-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2023-08-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A217396-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2023-08-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217396-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2023-08-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217396-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2023-08-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217396-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2023-08-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217396-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2023-08-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217396-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2023-08-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217396-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2023-08-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217396-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2023-08-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217396-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2023-08-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217396-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2023-08-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217396-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2023-08-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217396-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2023-08-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217396-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2023-08-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217396-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2023-08-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217396-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2023-08-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217396-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2023-08-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217396-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2023-08-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217396-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2023-08-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217396-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2023-08-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217396-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2023-08-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217396-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2023-08-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217396-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2023-08-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A217396-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2023-08-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A217396-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2023-08-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217396-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2023-08-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217396-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2023-08-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217396-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2023-08-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217396-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2023-08-14301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A217396-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A217396-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A217396-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A217396-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217396-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217396-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217396-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217396-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217396-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217396-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217396-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217396-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217396-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217396-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217396-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217396-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217396-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217396-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217396-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217396-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217396-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217396-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217396-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217396-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217396-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217396-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217396-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217396-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217396-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217396-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217396-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217396-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217396-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217396-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217396-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217396-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217396-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217396-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217396-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217396-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Losartan potassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOSARTAN POTASSIUM25 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
979485Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d5524d5-c76b-44af-e063-6294a90a2ef1Available 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
67046-1470-3Losartan potassium30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1470LOSARTAN POTASSIUM TABLET, FILM COATED [COUPLER LLC]1Current NDC, 1 package rows20250207_2d5524d5-c76b-44af-e063-6294a90a2ef1.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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan potassiumLOSARTAN POTASSIUMPreferred Pharmaceuticals Inc.05818573-0b40-4731-a9d1-152c708905bf2026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217396
application number: ANDA217396
Losartan potassiumLOSARTAN POTASSIUMNovadoz Pharmaceuticals LLC5edb843a-66ed-4950-9ed0-393e6a5d7c992026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217396
application number: ANDA217396
Losartan potassiumLOSARTAN POTASSIUMCoupler LLC2d5524d5-c76b-44af-e063-6294a90a2ef12025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217396
application number: ANDA217396
ndc (package): 67046-1470-3
ndc (product): 67046-1470
ndc11 (package): 67046147003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSN2d5524d5-c76b-44af-e063-6294a90a2ef11
979485losartan potassium 25 MG Oral TabletSCD2d5524d5-c76b-44af-e063-6294a90a2ef11
979485Losartan K+ 25 MG Oral TabletSY2d5524d5-c76b-44af-e063-6294a90a2ef11
979485Losartan Pot 25 MG Oral TabletSY2d5524d5-c76b-44af-e063-6294a90a2ef11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1470-36704614700330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1470-3) 2025-02-04NoNoCurrent