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

Product NDC
13668-385
11-digit product format
136680385
Labeler code
13668
Product ID
13668-385_ef5817f9-89bf-2fd7-e053-2a95a90a65b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/25 mg
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA203580
Marketing category
ANDA
Marketing start
2016-10-26
Marketing end
0000-00-00
Substance
AMLODIPINE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength
5 mg/1; mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13668-385DDiscontinued by firm2026-09-14
excluded packagepackage13668-38513668-385-05DDiscontinued by firm2026-09-14
excluded packagepackage13668-38513668-385-30DDiscontinued by firm2026-09-14
excluded packagepackage13668-38513668-385-90DDiscontinued 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 · 4 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage13668-385-30
excluded packagepackage13668-385-05
excluded packagepackage13668-385-90

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-385-30EA - Each13668-38527fce0de-8a0d-4038-8d13-dd57c9506a7c12018-03-08
13668-385-90EA - Each13668-385029671cb-a32a-47f9-8905-0e3202692ed812018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-385OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 20/5/12.5 MG (OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLET 20/5/12.5 MG) TABLET OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 40/5/12.5 MG (OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLET 40/5/12.5 MG) TABLET OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 40/5/25 MG (OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLET 40/5/25 MG) TABLET OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 40/10/12.5 MG (OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLET 40/10/12.5 MG) TABLET OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE 40/10/25 MG (OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE TABLET 40/10/25 MG) TABLET [TORRENT PHARMACEUTICALS LIMITED]11Legacy NDC20241213_85b8f9c6-aa53-4aa1-85d6-19f823d0d252.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-385-0513668038505500 TABLET in 1 BOTTLE (13668-385-05) 500 tablet2016-10-260000-00-00NoNoCurrent
13668-385-301366803853030 TABLET in 1 BOTTLE (13668-385-30) 30 tablet2016-10-260000-00-00NoNoCurrent
13668-385-7413668038574100 TABLET in 1 CARTON (13668-385-74) 100 tablet2016-10-260000-00-00NoNoCurrent
13668-385-901366803859090 TABLET in 1 BOTTLE (13668-385-90) 90 tablet2016-10-260000-00-00NoNoCurrent