Amlodipine and Olmesartan Medoxomil

Product NDC: 45865-901
11-digit product format: 458650901
Labeler code: 45865
Product ID: 45865-901_7d641e3c-5d84-dd95-e053-2991aa0a9423
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine and Olmesartan Medoxomil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: medsource pharmaceuticals
Application: ANDA091154
Marketing category: ANDA
Marketing start: 2016-10-26
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	45865-901		I	Inactivated by FDA		2026-08-17
excluded package	package	45865-901	45865-901-30	I	Inactivated by FDA		2026-08-17

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-901-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-901-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-901-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-901-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-901-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-901-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-901-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-901-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-901-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A091154-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2016-10-26
A091154-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2016-10-26
A091154-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2016-10-26
A091154-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2016-10-26

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 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091154-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2016-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091154-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2016-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091154-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2016-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091154-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2016-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091154-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2016-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091154-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2016-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091154-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2016-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091154-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2016-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091154-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2016-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091154-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2016-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091154-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2016-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091154-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2016-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091154-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2016-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091154-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2016-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091154-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2016-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091154-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2016-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091154-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2016-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091154-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2016-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091154-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2016-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091154-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2016-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091154-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2016-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091154-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2016-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091154-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2016-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091154-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2016-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091154-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2016-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091154-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2016-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091154-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2016-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091154-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2016-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091154-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2016-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091154-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2016-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091154-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2016-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091154-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2016-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091154-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2016-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091154-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2016-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091154-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2016-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091154-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2016-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091154-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	2016-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091154-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	2016-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091154-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	2016-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091154-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	2016-10-26	`d8e5a09893c0…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-901-30	2025-01-30	C162847	48780-1	2cef2736-7acc-d83d-e063-dadaa90ab31f	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-901-30	Amlodipine and Olmesartan Medoxomil	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-901	AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 1 package rows	20181220_7d641e3c-5d83-dd95-e053-2991aa0a9423.zip

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	7d641e3c-5d83-dd95-e053-2991aa0a9423	1
730866	amlodipine 10 MG / olmesartan medoxomil 40 MG Oral Tablet	SCD	7d641e3c-5d83-dd95-e053-2991aa0a9423	1
730866	amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 40 MG Oral Tablet	SY	7d641e3c-5d83-dd95-e053-2991aa0a9423	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-901-30	45865090130	30 TABLET, FILM COATED in 1 BOTTLE (45865-901-30)	2018-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine and Olmesartan Medoxomil	medsource pharmaceuticals	2018-12-19	HUMAN PRESCRIPTION DRUG LABEL	1