Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg

Product NDC
70518-2647
11-digit product format
705182647
Labeler code
70518
Product ID
70518-2647_cc0c8bd5-b1ab-11af-e053-2995a90a5efd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/25 mg
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203580
Marketing category
ANDA
Marketing start
2020-03-24
Marketing end
0000-00-00
Substance
OLMESARTAN MEDOXOMIL; AMLODIPINE; HYDROCHLOROTHIAZIDE
Active strength
40 mg/1; mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct70518-2647DDiscontinued by firm2026-09-14
excluded packagepackage70518-264770518-2647-0DDiscontinued by firm2026-09-14

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 packagepackage70518-2647-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2647-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2647-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2647-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2647-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2647-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2647-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2647-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2647-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2647-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2647-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-2647-0557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203580-001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 5MG BASE;12.5MG;20MGTABLET / ORALAB2016-10-26
A203580-002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 5MG BASE;12.5MG;40MGTABLET / ORALAB2016-10-26
A203580-003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 5MG BASE;25MG;40MGTABLET / ORALAB2016-10-26
A203580-004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 10MG BASE;12.5MG;40MGTABLET / ORALAB2016-10-26
A203580-005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMILEQ 10MG BASE;25MG;40MGTABLET / ORALAB2016-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A203580-001AB
A203580-002AB
A203580-003AB
A203580-004AB
A203580-005AB

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203580-001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;20MGTABLET / ORALAB2016-10-2684e616aacf4f…
2026-09-14 22:38:342026-08A203580-002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;40MGTABLET / ORALAB2016-10-2684e616aacf4f…
2026-09-14 22:38:342026-08A203580-003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;40MGTABLET / ORALAB2016-10-2684e616aacf4f…
2026-09-14 22:38:342026-08A203580-004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;40MGTABLET / ORALAB2016-10-2684e616aacf4f…
2026-09-14 22:38:342026-08A203580-005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;40MGTABLET / ORALAB2016-10-2684e616aacf4f…
2026-08-18 06:07:402026-07A203580-001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;20MGTABLET / ORAL2016-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07A203580-002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;40MGTABLET / ORALAB2016-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07A203580-003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;40MGTABLET / ORALAB2016-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07A203580-004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;40MGTABLET / ORAL2016-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07A203580-005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;40MGTABLET / ORAL2016-10-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203580-001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;20MGTABLET / ORAL2016-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203580-002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;40MGTABLET / ORALAB2016-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203580-003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;40MGTABLET / ORALAB2016-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203580-004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;40MGTABLET / ORAL2016-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203580-005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;40MGTABLET / ORAL2016-10-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203580-001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;20MGTABLET / ORAL2016-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203580-002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;40MGTABLET / ORALAB2016-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203580-003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;40MGTABLET / ORALAB2016-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203580-004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;40MGTABLET / ORAL2016-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203580-005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;40MGTABLET / ORAL2016-10-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203580-001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;20MGTABLET / ORAL2016-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203580-002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;40MGTABLET / ORALAB2016-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203580-003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;40MGTABLET / ORALAB2016-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203580-004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;40MGTABLET / ORAL2016-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203580-005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;40MGTABLET / ORAL2016-10-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203580-001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;20MGTABLET / ORALAB2016-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203580-002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;40MGTABLET / ORALAB2016-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203580-003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;40MGTABLET / ORALAB2016-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203580-004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;40MGTABLET / ORALAB2016-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203580-005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;40MGTABLET / ORALAB2016-10-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203580-001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;20MGTABLET / ORALAB2016-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203580-002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;40MGTABLET / ORALAB2016-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203580-003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;40MGTABLET / ORALAB2016-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203580-004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;40MGTABLET / ORALAB2016-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203580-005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;40MGTABLET / ORALAB2016-10-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203580-001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;20MGTABLET / ORALAB2016-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203580-002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;40MGTABLET / ORALAB2016-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203580-003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;40MGTABLET / ORALAB2016-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203580-004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;40MGTABLET / ORALAB2016-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203580-005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;40MGTABLET / ORALAB2016-10-2603ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 200 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203580-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203580-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A203580-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A203580-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A203580-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A203580-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203580-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203580-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203580-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203580-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203580-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203580-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203580-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203580-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203580-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203580-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203580-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203580-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203580-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203580-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203580-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203580-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203580-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203580-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203580-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203580-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203580-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203580-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203580-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203580-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203580-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203580-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203580-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203580-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203580-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203580-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203580-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203580-005AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203580-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203580-002AB1d8e5a09893c0…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2647-07051826470030 TABLET in 1 BOTTLE, PLASTIC (70518-2647-0) 30 tablet2020-03-240000-00-00NoNoCurrent