Amlodipine and olmesartan medoxomil

Product NDC: 70771-1189
11-digit product format: 707711189
Labeler code: 70771
Product ID: 70771-1189_adc1edc9-9897-4ba0-a14d-08c8d29f9369
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine and olmesartan medoxomil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA207771
Marketing category: ANDA
Marketing start: 2018-01-04
Marketing end: 0000-00-00
Substance: AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength: 10 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]
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70771-1189		D	Discontinued by firm	2026-10-20
excluded package	package	70771-1189	70771-1189-0	D	Discontinued by firm	2026-10-20
excluded package	package	70771-1189	70771-1189-1	D	Discontinued by firm	2026-10-20
excluded package	package	70771-1189	70771-1189-3	D	Discontinued by firm	2026-10-20
excluded package	package	70771-1189	70771-1189-4	D	Discontinued by firm	2026-10-20
excluded package	package	70771-1189	70771-1189-5	D	Discontinued by firm	2026-10-20
excluded package	package	70771-1189	70771-1189-9	D	Discontinued by firm	2026-10-20

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 · 14 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	70771-1189-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70771-1189-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70771-1189-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70771-1189-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70771-1189-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70771-1189-4	`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	70771-1189-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70771-1189-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70771-1189-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70771-1189-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70771-1189-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70771-1189-4	`f5e01cc5f278…`	`a2eaf40c39c3…`

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	TE codes	Approval date
A207771-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-09-22
A207771-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-09-22
A207771-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-09-22
A207771-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-09-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A207771-001	AB
A207771-002	AB
A207771-003	AB
A207771-004	AB

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	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A207771-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207771-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207771-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207771-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207771-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207771-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207771-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207771-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207771-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207771-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207771-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207771-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207771-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207771-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207771-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207771-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207771-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207771-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207771-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207771-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207771-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207771-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207771-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207771-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207771-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207771-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207771-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207771-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207771-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207771-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207771-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207771-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207771-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207771-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207771-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207771-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207771-001	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207771-002	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207771-003	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	2017-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207771-004	AMLODIPINE AND OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2017-09-22	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207771-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207771-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207771-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207771-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207771-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207771-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207771-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207771-004	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207771-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207771-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207771-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207771-004	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207771-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207771-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207771-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207771-004	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207771-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207771-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207771-003	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207771-004	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207771-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207771-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207771-003	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207771-004	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207771-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207771-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207771-003	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207771-004	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207771-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207771-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207771-003	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207771-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207771-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207771-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207771-003	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207771-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207771-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207771-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207771-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207771-004	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

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

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70771-1189-0	70771118900	1000 TABLET, FILM COATED in 1 BOTTLE (70771-1189-0)		2018-01-04	0000-00-00	No	No	Current
70771-1189-1	70771118901	100 TABLET, FILM COATED in 1 BOTTLE (70771-1189-1)		2018-01-04	0000-00-00	No	No	Current
70771-1189-3	70771118903	30 TABLET, FILM COATED in 1 BOTTLE (70771-1189-3)		2018-01-04	0000-00-00	No	No	Current
70771-1189-4	70771118904	10 BLISTER PACK in 1 CARTON (70771-1189-4) > 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1189-2)	10 blister pack	2018-01-04	0000-00-00	No	No	Current
70771-1189-5	70771118905	500 TABLET, FILM COATED in 1 BOTTLE (70771-1189-5)		2018-01-04	0000-00-00	No	No	Current
70771-1189-9	70771118909	90 TABLET, FILM COATED in 1 BOTTLE (70771-1189-9)		2018-01-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMLODIPINE and OLMESARTAN MEDOXOMIL Tablets	Zydus Lifesciences Limited	2022-10-13	HUMAN PRESCRIPTION DRUG LABEL	4