Losartan Potassium and Hydrochlorothiazide

Product NDC
63739-529
11-digit product format
637390529
Labeler code
63739
Product ID
63739-529_165e9b85-0a98-4574-95d1-a6706713b009
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA091629
Marketing category
ANDA
Marketing start
2011-06-01
Marketing end
0000-00-00
Substance
LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
Active strength
100 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63739-529DDiscontinued by firm2026-08-03
excluded packagepackage63739-52963739-529-10DDiscontinued by firm2026-08-03

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63739-529-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63739-529-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63739-529-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63739-529-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63739-529-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63739-529-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63739-529-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63739-529-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63739-529-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63739-529-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63739-529-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63739-529-10557ba5c1ecfa…9c80585c8c6e…

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
A091629-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM12.5MG;50MGTABLET / ORALAB2010-10-06
A091629-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM12.5MG;100MGTABLET / ORALAB2010-10-06
A091629-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM25MG;100MGTABLET / ORALABRS2010-01-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091629-001AB
A091629-002AB
A091629-003AB

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 UTC2026-02A091629-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091629-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091629-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2010-01-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091629-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091629-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091629-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2010-01-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A091629-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091629-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091629-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2010-01-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091629-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091629-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091629-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2010-01-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091629-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091629-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091629-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2010-01-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091629-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091629-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091629-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2010-01-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091629-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091629-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091629-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2010-01-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091629-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091629-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091629-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2010-01-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091629-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091629-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091629-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2010-01-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091629-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A091629-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A091629-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2010-01-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091629-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091629-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091629-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2010-01-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091629-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091629-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091629-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2010-01-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091629-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-10-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091629-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-10-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091629-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALABRS2010-01-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091629-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / 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 UTC2026-02A091629-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091629-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091629-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091629-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091629-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091629-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091629-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091629-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091629-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091629-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091629-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091629-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091629-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091629-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091629-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091629-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091629-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091629-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091629-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091629-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091629-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091629-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091629-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091629-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091629-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091629-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091629-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091629-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091629-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091629-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091629-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091629-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091629-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091629-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091629-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091629-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091629-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091629-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091629-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091629-001AB18072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-529-10EA - Each63739-52909612d5b-3ccf-4da5-8e89-6dfaec6a122912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.9f9cd7a7-be95-4ea8-8247-eb7ecbd369362026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091629
application number: ANDA091629
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsbe99cc03-ea65-4b17-bd9e-df7ae43077782026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091629
application number: ANDA091629
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsdc9512cf-db66-40e9-afcb-1d6a722772e82026-02-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091629
application number: ANDA091629
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutions5ec290f4-bf21-4c5b-a576-8eb2bd6bd3792026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091629
application number: ANDA091629
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDECoupler LLC44fd38d2-cb8b-d0e8-e063-6294a90a994e2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091629
application number: ANDA091629
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsbc8b9ae2-8263-4624-8629-4f856392f9da2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091629
application number: ANDA091629
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.dcb39c6b-430d-4b3d-ba6f-5bf1efe116aa2025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091629
application number: ANDA091629
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack60f3f17d-fd28-406d-97ca-9f01f5f1c72c2025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091629
application number: ANDA091629
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDENorthStar Rx LLC25318baf-9c2f-458f-b9ea-f52dabca49af2025-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091629
application number: ANDA091629
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limiteddc177d6c-c754-4379-8c2f-1cf6f52f950a2025-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091629
application number: ANDA091629
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.24ee299f-4466-45d4-9013-17791e1998bb2025-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091629
application number: ANDA091629
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirectRxcf4278a3-fbb7-a8ab-e053-2a95a90abc0f2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091629
application number: ANDA091629
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect_Rx8de04bf2-83dd-c494-e053-2a95a90abade2025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091629
application number: ANDA091629
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutions98b97680-474c-4e70-89dd-15bb497731252024-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091629
application number: ANDA091629
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LPa6e7d8a7-f969-4a21-ac28-93c77ed1fa632021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091629
application number: ANDA091629
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LP198d5151-7982-4639-9fe1-6573a45293482021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091629
application number: ANDA091629