Losartan Potassium

Product NDC
62332-028
11-digit product format
623320028
Labeler code
62332
Product ID
62332-028_a12a7eb0-196c-4ddc-ba64-2909f65b6f19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA090428
Marketing category
ANDA
Marketing start
2016-05-23
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
2026-12-31
Current FDA listing
Yes

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
A090428-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06
A090428-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06
A090428-003LOSARTAN 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
A090428-001AB
A090428-002AB
A090428-003AB

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 06:07:402026-07A090428-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090428-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090428-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090428-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090428-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090428-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090428-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090428-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090428-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090428-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090428-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090428-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090428-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090428-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090428-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090428-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090428-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090428-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090428-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090428-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090428-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090428-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090428-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090428-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090428-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090428-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090428-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090428-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090428-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090428-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090428-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090428-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090428-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090428-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090428-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090428-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090428-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090428-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090428-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090428-001LOSARTAN 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 06:07:402026-07A090428-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090428-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090428-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090428-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090428-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090428-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090428-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090428-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090428-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090428-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090428-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090428-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090428-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090428-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090428-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090428-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090428-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090428-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090428-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090428-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090428-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090428-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090428-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090428-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090428-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090428-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090428-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090428-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090428-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090428-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090428-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090428-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090428-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090428-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090428-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090428-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090428-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090428-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090428-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090428-001AB11e350fbaab3a…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOSARTAN POTASSIUM50 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
979480Internal RxNorm lookup
979485Internal RxNorm lookup
979492Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1dadbe02-289c-4312-9e65-40f3314dcc31Available 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
62332-028-30Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED3014
62332-028-31Losartan Potassium100 in 1 BOTTLETABLET, FILM COATED10014
62332-028-90Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED9014
62332-028-91Losartan Potassium1000 in 1 BOTTLETABLET, FILM COATED100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-028-30EA - Each62332-028f84d3bde-7d21-4968-ab9f-9441578af09e12016-10-06
62332-028-90EA - Each62332-028ca6c7082-ccf7-48ac-864d-7cd8b01a29de12016-10-06
62332-028-91EA - Each62332-02894e2a1ac-3b53-4b50-be63-a885a877d0c112016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-028LOSARTAN POTASSIUM TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 4 package rows20240704_1dadbe02-289c-4312-9e65-40f3314dcc31.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan PotassiumLOSARTAN POTASSIUMAlembic Pharmaceuticals Limitedeeb77c84-38d3-432d-914a-54b312b374bd2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090428
application number: ANDA090428
Losartan PotassiumLOSARTAN POTASSIUMAlembic Pharmaceuticals Inc.1dadbe02-289c-4312-9e65-40f3314dcc312025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090428
application number: ANDA090428
ndc (product): 62332-028

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979480losartan potassium 100 MG Oral TabletPSN1dadbe02-289c-4312-9e65-40f3314dcc3114
979485losartan potassium 25 MG Oral TabletPSN1dadbe02-289c-4312-9e65-40f3314dcc3114
979492losartan potassium 50 MG Oral TabletPSN1dadbe02-289c-4312-9e65-40f3314dcc3114
979480losartan potassium 100 MG Oral TabletSCD1dadbe02-289c-4312-9e65-40f3314dcc3114
979485losartan potassium 25 MG Oral TabletSCD1dadbe02-289c-4312-9e65-40f3314dcc3114
979492losartan potassium 50 MG Oral TabletSCD1dadbe02-289c-4312-9e65-40f3314dcc3114
979480Losartan K+ 100 MG Oral TabletSY1dadbe02-289c-4312-9e65-40f3314dcc3114
979485Losartan K+ 25 MG Oral TabletSY1dadbe02-289c-4312-9e65-40f3314dcc3114
979492Losartan K+ 50 MG Oral TabletSY1dadbe02-289c-4312-9e65-40f3314dcc3114
979480Losartan Pot 100 MG Oral TabletSY1dadbe02-289c-4312-9e65-40f3314dcc3114
979485Losartan Pot 25 MG Oral TabletSY1dadbe02-289c-4312-9e65-40f3314dcc3114
979492Losartan Pot 50 MG Oral TabletSY1dadbe02-289c-4312-9e65-40f3314dcc3114
979492losartan potassium 50 MG Oral TabletPSN4c6fca7d-9e36-4455-9e37-7ed2d64f64b22
979492losartan potassium 50 MG Oral TabletSCD4c6fca7d-9e36-4455-9e37-7ed2d64f64b22
979492Losartan K+ 50 MG Oral TabletSY4c6fca7d-9e36-4455-9e37-7ed2d64f64b22
979492Losartan Pot 50 MG Oral TabletSY4c6fca7d-9e36-4455-9e37-7ed2d64f64b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-028-306233200283030 TABLET, FILM COATED in 1 BOTTLE (62332-028-30) 2016-05-230000-00-00NoNoCurrent
62332-028-3162332002831100 TABLET, FILM COATED in 1 BOTTLE (62332-028-31) 2016-05-230000-00-00NoNoCurrent
62332-028-906233200289090 TABLET, FILM COATED in 1 BOTTLE (62332-028-90) 2016-05-230000-00-00NoNoCurrent
62332-028-91623320028911000 TABLET, FILM COATED in 1 BOTTLE (62332-028-91) 2016-05-230000-00-00NoNoCurrent