Amlodipine and Olmesartan Medoxomil

Product NDC: 60505-4585
11-digit product format: 605054585
Labeler code: 60505
Product ID: 60505-4585_575d2388-51c2-1057-b412-43d387051b92
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine and Olmesartan Medoxomil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA207807
Marketing category: ANDA
Marketing start: 2017-08-15
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: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	60505-4585		D	Discontinued by firm	2026-10-21
excluded package	package	60505-4585	60505-4585-3	D	Discontinued by firm	2026-10-21
excluded package	package	60505-4585	60505-4585-9	D	Discontinued by firm	2026-10-21

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60505-4585-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60505-4585-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60505-4585-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60505-4585-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60505-4585-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60505-4585-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60505-4585-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60505-4585-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60505-4585-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60505-4585-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60505-4585-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60505-4585-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60505-4585-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60505-4585-3	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60505-4585-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60505-4585-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60505-4585-9	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60505-4585-3	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60505-4585-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	60505-4585-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60505-4585-9	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	60505-4585-3	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60505-4585-9	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	60505-4585-3	`557ba5c1ecfa…`	`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-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A207807-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-07-05
A207807-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-07-05
A207807-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-07-05
A207807-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-07-05

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A207807-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-07-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207807-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-07-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207807-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-07-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207807-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-07-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207807-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207807-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207807-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207807-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-07-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207807-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207807-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207807-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207807-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207807-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207807-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207807-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207807-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207807-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207807-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207807-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207807-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207807-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207807-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207807-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207807-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207807-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207807-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207807-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207807-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207807-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-07-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207807-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-07-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207807-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-07-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207807-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207807-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-07-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207807-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-07-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207807-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-07-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207807-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207807-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2017-07-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207807-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2017-07-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207807-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2017-07-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207807-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2017-07-05	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207807-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207807-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207807-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207807-004	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa898d56-9495-d6f0-309b-68a5d8e3914a	Product name	4	20260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
265792b3-b999-c010-7364-a7db20b9d4d9	Product name	5	20250515
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
caadbc51-b731-1a7b-b91a-f7bb4a62554e	Product name	9	20240306
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
14c2c15b-f823-4ada-a40e-a440544294dc	Product name	1	20221207
a72887ef-d675-499f-af4b-78688f6855cd	Product name	1	20191002
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
a4484670-2869-6416-f6ff-03b1b3cbd1b0	Product name	2	20190415
4a27501f-a987-48a5-99b4-e983d4744d76	Product name	7	20181211
18600d07-613d-bf9c-2711-fe40c06f3393	Product name	5	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
bded1554-44de-900a-5297-403365d6d4b2	Product name	3	20170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1	Product name	1	20150316
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-4585-3	EA - Each	60505-4585	fbbb849f-ffef-4554-8c84-25b10ad24c9e	1	2017-11-06

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
730866	amLODIPine 10 MG / olmesartan medoxomil 40 MG Oral Tablet	PSN	9add85b6-a074-b8dc-e053-2a95a90a28ed	1
730866	amlodipine 10 MG / olmesartan medoxomil 40 MG Oral Tablet	SCD	9add85b6-a074-b8dc-e053-2a95a90a28ed	1
730866	amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 40 MG Oral Tablet	SY	9add85b6-a074-b8dc-e053-2a95a90a28ed	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine and Olmesartan Medoxomil	medsource pharmaceuticals \| Glenmark Pharmaceuticals Inc., USA	2019-12-29	HUMAN PRESCRIPTION DRUG LABEL	1
Amlodipine and Olmesartan Medoxomil	Apotex Corp. \| Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Ltd.	2017-02-21	HUMAN PRESCRIPTION DRUG LABEL	1