Amlodipine and olmesartan medoxomil

Product NDC: 59746-528
Requested package NDC: 59746-528-30
11-digit product format: 597460528
Labeler code: 59746
Product ID: 59746-528_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: 10 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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59746-528	59746-528-30	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A207450-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-05-15
A207450-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-05-15
A207450-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-05-15
A207450-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-05-15

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207450-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207450-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207450-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207450-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207450-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207450-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207450-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207450-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207450-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207450-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207450-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207450-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207450-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207450-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207450-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207450-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207450-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207450-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207450-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207450-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207450-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207450-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207450-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207450-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207450-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207450-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207450-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207450-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207450-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207450-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207450-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207450-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207450-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-05-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207450-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-05-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207450-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-05-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207450-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207450-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-05-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207450-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-05-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207450-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-05-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207450-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-05-15	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A207450-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207450-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207450-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207450-004	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207450-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207450-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207450-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207450-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207450-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207450-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207450-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207450-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207450-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207450-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207450-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207450-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207450-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207450-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207450-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207450-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207450-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207450-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207450-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207450-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207450-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207450-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207450-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207450-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207450-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207450-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207450-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207450-004	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
59746-528-01	2023-10-27	These 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
59746-528-10	2023-10-27	These 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
59746-528-30	2023-10-27	These 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
59746-528-90	2023-10-27	These 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
59746-528-01	2023-01-30	These 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
59746-528-10	2023-01-30	These 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
59746-528-30	2023-01-30	These 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
59746-528-90	2023-01-30	These 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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE
6M97XTV3HD	OLMESARTAN MEDOXOMIL	144689-63-4	OLMESARTAN MEDOXOMIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59746-528-30	59746052830	30 TABLET, FILM COATED in 1 BOTTLE (59746-528-30)	2017-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine and olmesartan medoxomil	Jubilant Cadista Pharmaceuticals Inc. \| Jubilant Generics Limited	2017-05-19	HUMAN PRESCRIPTION DRUG LABEL	5