FDA.reportPublic FDA data

Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 20/5/12.5 mg

Product NDC
13668-397
11-digit product format
136680397
Labeler code
13668
Product ID
13668-397_ef5817f9-89bf-2fd7-e053-2a95a90a65b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 20/5/12.5 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 productproduct13668-397DDiscontinued by firm2026-10-15
excluded packagepackage13668-39713668-397-05DDiscontinued by firm2026-10-15
excluded packagepackage13668-39713668-397-30DDiscontinued by firm2026-10-15
excluded packagepackage13668-39713668-397-90DDiscontinued by firm2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A203580-001OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;20MGTABLET / ORALAB2016-10-26c2088c7a36db…
2026-10-15 13:18:302026-09A203580-002OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;12.5MG;40MGTABLET / ORALAB2016-10-26c2088c7a36db…
2026-10-15 13:18:302026-09A203580-003OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 5MG BASE;25MG;40MGTABLET / ORALAB2016-10-26c2088c7a36db…
2026-10-15 13:18:302026-09A203580-004OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;12.5MG;40MGTABLET / ORALAB2016-10-26c2088c7a36db…
2026-10-15 13:18:302026-09A203580-005OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDEEQ 10MG BASE;25MG;40MGTABLET / ORALAB2016-10-26c2088c7a36db…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-08 23:34 UTC2022-04A203580-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203580-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203580-005AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203580-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203580-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203580-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203580-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203580-005AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203580-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203580-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203580-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203580-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203580-005AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203580-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203580-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203580-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203580-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203580-005AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203580-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203580-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203580-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203580-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203580-005AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203580-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203580-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203580-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203580-004AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203580-005AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203580-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A203580-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A203580-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A203580-004AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A203580-005AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203580-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A203580-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A203580-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A203580-004AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A203580-005AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203580-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A203580-002AB1c0c555d07b60…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-397-30EA - Each13668-39761231524-8dca-498d-ae09-0ed5680c925012018-03-08
13668-397-90EA - Each13668-397989b0488-2908-4adc-b064-ae93316ae4ab12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-397OLMESARTAN 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
13668-397-0513668039705500 TABLET in 1 BOTTLE (13668-397-05) 500 tablet2016-10-260000-00-00NoNoCurrent
13668-397-301366803973030 TABLET in 1 BOTTLE (13668-397-30) 30 tablet2016-10-260000-00-00NoNoCurrent
13668-397-7413668039774100 TABLET in 1 BOTTLE (13668-397-74) 100 tablet2016-10-260000-00-00NoNoCurrent
13668-397-901366803979090 TABLET in 1 BOTTLE (13668-397-90) 90 tablet2016-10-260000-00-00NoNoCurrent