Amlodipine Besylate

Product NDC: 51079-451
11-digit product format: 510790451
Labeler code: 51079
Product ID: 51079-451_7b2018ec-84d3-6b95-e053-2a91aa0a2626
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine besylate
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Institutional Inc.
Application: ANDA076418
Marketing category: ANDA
Marketing start: 2007-04-02
Marketing end: 2019-11-30
Substance: AMLODIPINE BESYLATE
Active strength: 5 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	51079-451		D	Discontinued by firm	2026-08-17
excluded package	package	51079-451	51079-451-20	D	Discontinued by firm	2026-08-17
excluded package	package	51079-451	51079-451-56	D	Discontinued by firm	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 · 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	51079-451-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51079-451-56	`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	51079-451-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51079-451-56	`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	51079-451-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51079-451-56	`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	51079-451-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51079-451-56	`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	51079-451-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51079-451-56	`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	51079-451-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51079-451-56	`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	51079-451-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51079-451-56	`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	51079-451-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51079-451-56	`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	51079-451-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51079-451-56	`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	51079-451-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51079-451-56	`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	51079-451-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51079-451-56	`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	51079-451-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	51079-451-56	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076418-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2005-10-03
A076418-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2005-10-03
A076418-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2005-10-03

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 4 · 126 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	A076418-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2005-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076418-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2005-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076418-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2005-10-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076418-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2005-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076418-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2005-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076418-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2005-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076418-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2005-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076418-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2005-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076418-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2005-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076418-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2005-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076418-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2005-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076418-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2005-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076418-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2005-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076418-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2005-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076418-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2005-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076418-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2005-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076418-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2005-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076418-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2005-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076418-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2005-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076418-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2005-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076418-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2005-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076418-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2005-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076418-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2005-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076418-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2005-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076418-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2005-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076418-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2005-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076418-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2005-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076418-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2005-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076418-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2005-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076418-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2005-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076418-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2005-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076418-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2005-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076418-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2005-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076418-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2005-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076418-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2005-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076418-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2005-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076418-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2005-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076418-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2005-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076418-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2005-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076418-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2005-10-03	`1e350fbaab3a…`

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	A076418-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076418-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076418-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076418-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076418-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076418-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076418-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076418-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076418-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076418-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076418-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076418-003	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51079-451-01	EA - Each	51079-451	6f075194-15d6-405c-952d-94d589518b5b	1	2012-07-24
51079-451-17	EA - Each	51079-451	3549b0c6-42f1-49d1-a7d2-f940db36be71	1	2012-07-24
51079-451-19	EA - Each	51079-451	219799ce-6652-4017-9be7-ddc9b5ff323a	1	2012-07-24
51079-451-20	EA - Each	51079-451	a7cc4e38-b782-427a-82f8-9b49a1d5feeb	1	2012-07-24
51079-451-30	EA - Each	51079-451	586777fd-6058-4e21-b4e6-dab8d62b521c	1	2013-07-02
51079-451-56	EA - Each	51079-451	c812d39b-8a4f-4b12-93a6-a2b32e3c93e5	1	2012-07-24
51079-451-69	EA - Each	51079-451	26277842-ae8e-4d23-bd9b-788faf9b4515	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]	8
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]	8
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]	8
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE BESYLATE TABLET [MYLAN INSTITUTIONAL INC.]	8