FDA.reportPublic FDA data

Amlodipine and olmesartan medoxomil

Product NDC
59746-527
Requested package NDC
59746-527-30
11-digit product format
597460527
Labeler code
59746
Product ID
59746-527_660f89b1-ff32-4d61-aa48-56d9e6c15dce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA207450
Marketing category
ANDA
Marketing start
2017-05-15
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength
5 mg/1; mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59746-52759746-527-30DDiscontinued by firm2026-10-16

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207450-001AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-05-15
A207450-002AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-05-15
A207450-003AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-05-15
A207450-004AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE BESYLATE; OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-05-15

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 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A207450-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-05-15c2088c7a36db…
2026-10-15 13:18:302026-09A207450-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-05-15c2088c7a36db…
2026-10-15 13:18:302026-09A207450-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-05-15c2088c7a36db…
2026-10-15 13:18:302026-09A207450-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-05-15c2088c7a36db…
2026-09-14 22:38:342026-08A207450-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-05-1584e616aacf4f…
2026-09-14 22:38:342026-08A207450-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-05-1584e616aacf4f…
2026-09-14 22:38:342026-08A207450-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-05-1584e616aacf4f…
2026-09-14 22:38:342026-08A207450-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-05-1584e616aacf4f…
2026-08-18 06:07:402026-07A207450-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-05-15caaa826d4ba7…
2026-08-18 06:07:402026-07A207450-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-05-15caaa826d4ba7…
2026-08-18 06:07:402026-07A207450-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-05-15caaa826d4ba7…
2026-08-18 06:07:402026-07A207450-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-05-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207450-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-05-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207450-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-05-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207450-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-05-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207450-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207450-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-05-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207450-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-05-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207450-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-05-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207450-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207450-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-05-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207450-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-05-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207450-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-05-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207450-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207450-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-05-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207450-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-05-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207450-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-05-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207450-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207450-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-05-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207450-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-05-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207450-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-05-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207450-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207450-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-05-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207450-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-05-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207450-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-05-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207450-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207450-001AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;20MGTABLET / ORAL2017-05-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207450-002AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 5MG BASE;40MGTABLET / ORAL2017-05-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207450-003AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;20MGTABLET / ORAL2017-05-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207450-004AMLODIPINE AND OLMESARTAN MEDOXOMILEQ 10MG BASE;40MGTABLET / ORAL2017-05-152680178bc6a6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A207450-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207450-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207450-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207450-004AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207450-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207450-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207450-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207450-004AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207450-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A207450-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A207450-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A207450-004AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207450-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A207450-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A207450-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A207450-004AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207450-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207450-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207450-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A207450-004AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207450-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A207450-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A207450-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A207450-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207450-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207450-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207450-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A207450-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207450-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207450-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207450-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A207450-004AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
59746-527-012023-10-27These highlights do not include all the information needed to use AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS. AMLODIPINE AND OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2007
59746-527-102023-10-27These highlights do not include all the information needed to use AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS. AMLODIPINE AND OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2007
59746-527-302023-10-27These highlights do not include all the information needed to use AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS. AMLODIPINE AND OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2007
59746-527-902023-10-27These highlights do not include all the information needed to use AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS. AMLODIPINE AND OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2007
59746-527-012023-01-30These highlights do not include all the information needed to use AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS. AMLODIPINE AND OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2007
59746-527-102023-01-30These highlights do not include all the information needed to use AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS. AMLODIPINE AND OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2007
59746-527-302023-01-30These highlights do not include all the information needed to use AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS. AMLODIPINE AND OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2007
59746-527-902023-01-30These highlights do not include all the information needed to use AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLETS. AMLODIPINE AND OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59746-527-305974605273030 TABLET, FILM COATED in 1 BOTTLE (59746-527-30) 2017-05-150000-00-00NoNoCurrent