Losartan Potassium and Hydrochlorothiazide

Product NDC
70518-3420
11-digit product format
705183420
Labeler code
70518
Product ID
70518-3420_4f0bfa27-7a0b-4faf-e063-6294a90a730a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
losartan potassium and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204901
Marketing category
ANDA
Marketing start
2022-05-16
Substance
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Active strength
25; 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
2027-12-31
Current FDA listing
Yes

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 packagepackage70518-342070518-3420-0DDiscontinued by firm2026-08-11
excluded packagepackage70518-342070518-3420-3DDiscontinued by firm2026-08-11

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 · 14 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0570518-3420-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-3420-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2670518-3420-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-3420-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3170518-3420-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2870518-3420-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2170518-3420-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1070518-3420-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3170518-3420-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2070518-3420-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1070518-3420-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0870518-3420-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0370518-3420-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0970518-3420-0557ba5c1ecfa…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
A204901-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM12.5MG;50MGTABLET / ORALAB2017-11-06
A204901-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM12.5MG;100MGTABLET / ORALAB2017-11-06
A204901-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM25MG;100MGTABLET / ORALAB2017-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204901-001AB
A204901-002AB
A204901-003AB

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 UTC2026-02A204901-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2017-11-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204901-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2017-11-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204901-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2017-11-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204901-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2017-11-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204901-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2017-11-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204901-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2017-11-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A204901-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2017-11-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204901-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2017-11-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204901-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2017-11-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204901-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2017-11-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204901-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2017-11-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204901-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2017-11-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204901-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2017-11-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204901-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2017-11-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204901-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2017-11-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204901-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2017-11-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204901-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2017-11-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204901-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2017-11-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204901-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2017-11-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204901-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2017-11-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204901-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2017-11-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204901-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2017-11-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204901-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2017-11-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204901-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2017-11-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204901-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2017-11-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204901-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2017-11-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204901-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2017-11-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204901-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2017-11-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A204901-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2017-11-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A204901-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2017-11-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204901-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2017-11-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204901-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2017-11-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204901-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2017-11-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204901-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2017-11-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204901-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2017-11-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204901-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2017-11-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204901-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2017-11-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204901-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2017-11-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204901-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2017-11-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204901-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2017-11-068072bd15b7f6…

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 UTC2026-02A204901-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204901-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204901-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204901-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204901-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204901-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204901-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204901-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204901-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204901-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204901-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204901-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204901-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204901-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204901-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204901-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204901-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204901-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204901-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204901-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204901-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204901-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204901-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204901-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204901-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204901-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204901-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204901-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204901-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204901-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204901-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204901-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204901-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204901-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204901-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204901-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204901-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204901-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204901-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204901-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOSARTAN POTASSIUM25 mg/1
HYDROCHLOROTHIAZIDE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ST302B24AInternal UNII lookup
0J48LPH2THInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
446e6998-01f6-4de0-be57-7fecf5448e95Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
0d341e63-aee5-498b-bf9a-b53a43963acfProduct name120260105
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
de29c5c0-90ba-29da-d7ab-0500274708beProduct name620241009
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3420-0Losartan Potassium and Hydrochlorothiazide30 in 1 BOXTABLET, FILM COATED3010
70518-3420-1Losartan Potassium and Hydrochlorothiazide1 in 1 POUCHTABLET, FILM COATED110
70518-3420-2Losartan Potassium and Hydrochlorothiazide90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9010
70518-3420-3Losartan Potassium and Hydrochlorothiazide30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3010
70518-3420-4Losartan Potassium and Hydrochlorothiazide90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3420LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 5 package rows20240709_446e6998-01f6-4de0-be57-7fecf5448e95.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDESt. Mary's Medical Park Pharmacyeac57b4c-e79b-8d35-e053-2a95a90a9d252026-06-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEQPharma, Inc499208e5-21ab-d4fe-e063-6294a90a9a782026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.03c0ec8d-9daf-43e8-8a4e-a2ddc3573ca72026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.446e6998-01f6-4de0-be57-7fecf5448e952026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
ndc (product): 70518-3420
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEREMEDYREPACK INC.fd07d24c-6db1-4f6b-b226-68abba3a33212026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect Rxd838e918-2463-79f6-e053-2a95a90a948d2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDESolco Healthcare US, LLC6d677f9e-c0e4-4d6e-bea2-a58e986e46352025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LPbe81ba65-c434-4287-97d3-cd11d60316362025-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.46cf633d-70a5-4d3b-b349-ad74c23ddace2025-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepacke0f63126-6890-48bf-9c25-444dc5974ecd2025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack8b36fa56-4274-4fc6-bdba-ca7a399b2b212025-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect Rxd8284747-07b6-9775-e053-2a95a90ad52d2025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect Rxd88ad738-a915-7679-e053-2a95a90a58c72025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEQuality Care Products, LLCa6241e63-1952-4dfa-ba94-c406059501dd2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack927315ca-211b-4976-b228-cf544f7e52592024-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsaf44b2b0-1204-43c9-8ec1-d081d35b8f2b2024-06-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LPc6ed6f74-0eca-4f99-8c7e-dd3f56167f012024-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEA-S Medication Solutions6bd15e74-2ca2-49c8-8c01-0a647d3fa5df2024-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack42942482-1f54-4c7f-9d5f-4aaf20abb3e32023-11-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204901
application number: ANDA204901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979471losartan potassium 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN446e6998-01f6-4de0-be57-7fecf5448e9510
979471hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral TabletSCD446e6998-01f6-4de0-be57-7fecf5448e9510
979471HCTZ 25 MG / Losartan K+ 100 MG Oral TabletSY446e6998-01f6-4de0-be57-7fecf5448e9510
979471HCTZ 25 MG / Losartan Pot 100 MG Oral TabletSY446e6998-01f6-4de0-be57-7fecf5448e9510
979471HCTZ 25 MG / losartan potassium 100 MG Oral TabletSY446e6998-01f6-4de0-be57-7fecf5448e9510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3420-07051834200030 POUCH in 1 BOX (70518-3420-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-3420-1) 30 pouch2022-05-160000-00-00NoNoCurrent
70518-3420-1705183420011 in 1 POUCHHistorical
70518-3420-27051834200290 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3420-2) 2022-08-110000-00-00NoNoCurrent
70518-3420-37051834200330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3420-3) 2022-12-130000-00-00NoNoCurrent
70518-3420-47051834200490 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3420-4) 2025-09-13NoNoCurrent