Losartan Potassium and Hydrochlorothiazide

Product NDC
66116-450
11-digit product format
661160450
Labeler code
66116
Product ID
66116-450_7306dad3-30ed-47ed-9fb9-d5d9e1ec5247
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Losartan Potassium and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA077157
Marketing category
ANDA
Marketing start
2010-12-20
Marketing end
0000-00-00
Substance
LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
Active strength
50 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
E
Listing certified through
2017-12-31
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 productproduct66116-450IInactivated by FDA2026-08-03
excluded packagepackage66116-45066116-450-30IInactivated by FDA2026-08-03

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 · 44 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 packagepackage66116-450-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66116-450-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66116-450-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66116-450-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66116-450-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66116-450-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66116-450-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66116-450-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66116-450-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66116-450-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66116-450-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66116-450-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66116-450-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66116-450-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66116-450-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66116-450-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66116-450-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66116-450-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66116-450-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66116-450-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66116-450-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66116-450-30110d247fa046…a55b01930146…

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
A077157-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM12.5MG;50MGTABLET / ORALAB2010-04-06
A077157-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM12.5MG;100MGTABLET / ORALAB2010-04-06
A077157-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM25MG;100MGTABLET / ORALAB2010-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077157-001AB
A077157-002AB
A077157-003AB

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 UTC2026-02A077157-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077157-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077157-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2010-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077157-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077157-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077157-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2010-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077157-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077157-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077157-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2010-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077157-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077157-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077157-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2010-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077157-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077157-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077157-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2010-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077157-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077157-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077157-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2010-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077157-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077157-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077157-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2010-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077157-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077157-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077157-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2010-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077157-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077157-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077157-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2010-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077157-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077157-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077157-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2010-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077157-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077157-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077157-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2010-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077157-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077157-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077157-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2010-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077157-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-04-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077157-002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;100MGTABLET / ORALAB2010-04-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077157-003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE25MG;100MGTABLET / ORALAB2010-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077157-001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE12.5MG;50MGTABLET / ORALAB2010-04-068072bd15b7f6…

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 UTC2026-02A077157-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077157-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077157-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077157-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077157-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077157-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077157-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077157-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077157-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077157-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077157-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077157-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077157-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077157-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077157-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077157-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077157-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077157-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077157-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077157-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077157-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077157-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077157-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077157-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077157-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077157-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077157-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077157-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077157-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077157-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077157-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077157-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077157-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077157-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077157-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077157-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077157-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077157-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077157-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077157-001AB18072bd15b7f6…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66116-450-302019-11-13C16284748780-197449f38-cf41-f6ea-e053-dbdaa90aa703LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS 7367 7369 7368 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-450-30Losartan Potassium and Hydrochlorothiazide30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MEDVANTX, INC.]1
LOSARTAN POTASSIUMACTIVE INGREDIENT3ST302B24ALOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MEDVANTX, INC.]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MEDVANTX, INC.]1
LOSARTANACTIVE MOIETYJMS50MPO89LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MEDVANTX, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MEDVANTX, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MEDVANTX, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MEDVANTX, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MEDVANTX, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ALOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MEDVANTX, INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MEDVANTX, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MEDVANTX, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-450LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MEDVANTX, INC.]1Legacy NDC, 1 package rows20111110_7306dad3-30ed-47ed-9fb9-d5d9e1ec5247.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEQPharma Inc8d2e01fe-6d4b-4c13-a03c-77f72b6357152026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077157
application number: ANDA077157
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDETeva Pharmaceuticals USA, Inc.deafd195-7a1b-4ad8-a371-2cd9f433dea52025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077157
application number: ANDA077157
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect_Rx8de04bf2-83dd-c494-e053-2a95a90abade2025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077157
application number: ANDA077157
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.72c97b7f-d945-5106-e053-2a91aa0a9b3b2024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077157
application number: ANDA077157
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LP8d992a4c-8740-4636-928f-bb808eae33362023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077157
application number: ANDA077157
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEProficient Rx LP7897d182-2859-4a40-af4d-aaa9d9720fd92021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077157
application number: ANDA077157

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979468losartan potassium 50 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN7306dad3-30ed-47ed-9fb9-d5d9e1ec52471
979468hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral TabletSCD7306dad3-30ed-47ed-9fb9-d5d9e1ec52471
979468HCTZ 12.5 MG / Losartan K+ 50 MG Oral TabletSY7306dad3-30ed-47ed-9fb9-d5d9e1ec52471
979468HCTZ 12.5 MG / Losartan Pot 50 MG Oral TabletSY7306dad3-30ed-47ed-9fb9-d5d9e1ec52471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-450-306611604503030 in 1 BOTTLEHistorical