Losartan Potassium

Product NDC
71610-155
11-digit product format
716100155
Labeler code
71610
Product ID
71610-155_c35e4e9d-906b-4eef-876b-b362108a5ccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA203835
Marketing category
ANDA
Marketing start
2015-08-19
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 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
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 · 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 UTC2026-02A203835-001LOSARTAN 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…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203835-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2015-08-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203835-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2015-08-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203835-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2015-08-128072bd15b7f6…

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 UTC2026-02A203835-001AB1011fe1cb6892…
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…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203835-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203835-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203835-001AB18072bd15b7f6…

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
3bcbcb6c-ee8d-44b1-9c78-92712291e891Available 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
71610-155-30Losartan Potassium30 in 1 BOTTLETABLET, FILM COATED301
71610-155-45Losartan Potassium45 in 1 BOTTLETABLET, FILM COATED451
71610-155-60Losartan Potassium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-155-30EA - Each71610-15562e0dadb-8ca9-4a90-903c-fa04b432717712018-12-13
71610-155-45EA - Each71610-155f5b2969e-9a40-4017-93bf-d5d40b12f7ab12018-12-13
71610-155-60EA - Each71610-155c2a5e801-48d6-49a4-acc9-aa07866148ce12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-155LOSARTAN POTASSIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 3 package rows20181016_3bcbcb6c-ee8d-44b1-9c78-92712291e891.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 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Losartan PotassiumLOSARTAN POTASSIUMA-S Medication Solutions67ffab1a-9e80-48dd-a6c6-1b586161fe502025-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203835
application number: ANDA203835

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979485losartan potassium 25 MG Oral TabletPSN3bcbcb6c-ee8d-44b1-9c78-92712291e8911
979485losartan potassium 25 MG Oral TabletSCD3bcbcb6c-ee8d-44b1-9c78-92712291e8911
979485Losartan K+ 25 MG Oral TabletSY3bcbcb6c-ee8d-44b1-9c78-92712291e8911
979485Losartan Pot 25 MG Oral TabletSY3bcbcb6c-ee8d-44b1-9c78-92712291e8911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-155-307161001553030 TABLET, FILM COATED in 1 BOTTLE (71610-155-30) 2018-09-210000-00-00NoNoCurrent
71610-155-457161001554545 TABLET, FILM COATED in 1 BOTTLE (71610-155-45) 2018-09-210000-00-00NoNoCurrent
71610-155-607161001556090 TABLET, FILM COATED in 1 BOTTLE (71610-155-60) 2018-09-210000-00-00NoNoCurrent