Amlodipine Besylate

Product NDC: 0054-0100
11-digit product format: 000540100
Labeler code: 0054
Product ID: 0054-0100_236a1b97-e056-4b91-b263-c53e95275adf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine Besylate
Dosage form: TABLET
Route: ORAL
Labeler: West-Ward Pharmaceuticals Corp.
Application: ANDA077262
Marketing category: ANDA
Marketing start: 2007-07-09
Marketing end: 2020-08-20
Substance: AMLODIPINE BESYLATE
Active strength: 3 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	0054-0100		D	Discontinued by firm	2026-08-17
excluded package	package	0054-0100	0054-0100-22	D	Discontinued by firm	2026-08-17
excluded package	package	0054-0100	0054-0100-31	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	0054-0100-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0054-0100-22	`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	0054-0100-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0054-0100-22	`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	0054-0100-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0054-0100-22	`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	0054-0100-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0054-0100-22	`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	0054-0100-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0054-0100-22	`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	0054-0100-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0054-0100-22	`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	0054-0100-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0054-0100-22	`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	0054-0100-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0054-0100-22	`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	0054-0100-31	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0054-0100-22	`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	0054-0100-31	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0054-0100-22	`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	0054-0100-31	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0054-0100-22	`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	0054-0100-31	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0054-0100-22	`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
A077262-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-09
A077262-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-07-09
A077262-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-07-09

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	A077262-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077262-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077262-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077262-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077262-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077262-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077262-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077262-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077262-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077262-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077262-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077262-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077262-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077262-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-07-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077262-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077262-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077262-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-07-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077262-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077262-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077262-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-07-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077262-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077262-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077262-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-07-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077262-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077262-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077262-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-07-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077262-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077262-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077262-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-07-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077262-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077262-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077262-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-07-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077262-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077262-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077262-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-07-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077262-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077262-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077262-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	2007-07-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077262-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	2007-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077262-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	2007-07-09	`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	A077262-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077262-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077262-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077262-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077262-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077262-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077262-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077262-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077262-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077262-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077262-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077262-003	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
0054-0100-22	EA - Each	0054-0100	a9c5d932-e0a8-4ff8-ab21-29afa4d2aa01	1	2012-07-24
0054-0100-31	EA - Each	0054-0100	ef8b2bf7-61b2-49a4-8c2d-5230735d6db8	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC]	9
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC]	9
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	AMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE BESYLATE TABLET [ROXANE LABORATORIES, INC]	9

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine Besylate	West-Ward Pharmaceuticals Corp. \| West-Ward Columbus Inc.	2020-01-15	HUMAN PRESCRIPTION DRUG LABEL	14