Amlodipine and Valsartan

Product NDC: 45865-889
11-digit product format: 458650889
Labeler code: 45865
Product ID: 45865-889_7dcc6802-acaf-aba1-e053-2991aa0adb70
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine and Valsartan
Dosage form: TABLET
Route: ORAL
Labeler: medsource pharmaceuticals
Application: ANDA090245
Marketing category: ANDA
Marketing start: 2015-03-30
Marketing end: 0000-00-00
Substance: AMLODIPINE BESYLATE; VALSARTAN
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: 2019-12-31
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	45865-889		I	Inactivated by FDA		2026-10-05
excluded package	package	45865-889	45865-889-49	I	Inactivated by FDA		2026-10-05

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 · 42 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	45865-889-49	`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	45865-889-49	`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	45865-889-49	`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	45865-889-49	`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	45865-889-49	`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	45865-889-49	`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	45865-889-49	`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	45865-889-49	`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	45865-889-49	`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	45865-889-49	`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	45865-889-49	`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	45865-889-49	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	45865-889-49	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	45865-889-49	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	45865-889-49	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	45865-889-49	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	45865-889-49	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	45865-889-49	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	45865-889-49	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	45865-889-49	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	45865-889-49	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	2015-03-30
A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	2015-03-30
A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	2015-03-30
A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	AMLODIPINE BESYLATE; VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	2015-03-30

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 · 172 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
2026-09-14 22:38:34	2026-08	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL		2015-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL		2015-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL		2015-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL		2015-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL		2015-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL		2015-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL		2015-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL		2015-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090245-001	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090245-002	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;160MG	TABLET / ORAL	AB	2015-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090245-003	AMLODIPINE BESYLATE AND VALSARTAN	EQ 5MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090245-004	AMLODIPINE BESYLATE AND VALSARTAN	EQ 10MG BASE;320MG	TABLET / ORAL	AB	2015-03-30	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090245-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090245-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090245-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090245-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090245-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090245-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090245-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090245-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090245-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090245-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090245-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090245-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090245-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090245-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090245-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090245-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090245-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090245-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090245-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090245-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090245-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090245-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090245-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090245-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090245-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090245-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090245-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090245-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090245-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090245-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090245-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090245-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090245-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090245-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090245-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090245-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090245-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090245-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090245-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090245-004	AB	1	`d06236e962d9…`

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
692a3434-fece-49c6-9b7d-ed7aefc52b50	Product name	3	20260317
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
e7dfdaab-7cf9-4f89-804c-eff5108d94d1	Product name	9	20250305
b6abae2f-ee27-47bc-b150-54dc8d969483	Product name	2	20250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519	Product name	2	20231208
14c2c15b-f823-4ada-a40e-a440544294dc	Product name	1	20221207
a72887ef-d675-499f-af4b-78688f6855cd	Product name	1	20191002
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
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
bded1554-44de-900a-5297-403365d6d4b2	Product name	3	20170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1	Product name	1	20150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
f5231d08-c52b-a5a0-ba93-675895c292be	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-889-49	2020-01-31	C162847	48780-1	9d75b9d0-1ccf-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use AMLODIPINE AND VALSARTAN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND VALSARTAN TABLETS. AMLODIPINE and VALSARTAN 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
45865-889-49	Amlodipine and Valsartan	100 in 1 BOTTLE	TABLET	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-889	AMLODIPINE AND VALSARTAN TABLET [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 1 package rows	20181225_7dcc6802-acae-aba1-e053-2991aa0adb70.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine and Valsartan	AMLODIPINE AND VALSARTAN	Lupin Pharmaceuticals, Inc.	35086164-bf92-4b3c-9845-f8cd7464c7d6	2023-12-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090245 application number: ANDA090245

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE
80M03YXJ7I	VALSARTAN	137862-53-4	VALSARTAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
722126	amLODIPine 10 MG / valsartan 160 MG Oral Tablet	PSN	7dcc6802-acae-aba1-e053-2991aa0adb70	1
722126	amlodipine 10 MG / valsartan 160 MG Oral Tablet	SCD	7dcc6802-acae-aba1-e053-2991aa0adb70	1
722126	amlodipine (as amlodipine besylate) 10 MG / valsartan 160 MG Oral Tablet	SY	7dcc6802-acae-aba1-e053-2991aa0adb70	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
45865-889-49	45865088949	100 in 1 BOTTLE	Historical