Amlodipine Besylate

Product NDC: 55154-4331
Requested package NDC: 55154-4331-0
11-digit product format: 551544331
Labeler code: 55154
Product ID: 55154-4331_a286c930-7d0e-410d-9384-f89766854430
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine Besylate
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health
Application: ANDA078552
Marketing category: ANDA
Marketing start: 2014-01-10
Marketing end: 0000-00-00
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55154-4331	55154-4331-0	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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	TE codes	Approval date
A078552-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08
A078552-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08
A078552-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078552-001	AB
A078552-002	AB
A078552-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078552-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-04-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078552-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078552-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-04-08	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078552-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078552-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078552-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078552-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078552-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078552-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078552-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078552-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078552-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078552-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078552-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078552-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078552-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078552-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078552-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078552-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078552-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078552-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078552-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078552-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078552-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078552-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078552-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078552-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078552-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078552-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078552-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078552-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078552-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078552-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078552-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078552-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078552-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078552-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078552-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078552-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078552-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078552-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078552-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078552-001	AB	1	`1e350fbaab3a…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE TABLET [CARDINAL HEALTH]	2
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE TABLET [CARDINAL HEALTH]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE TABLET [CARDINAL HEALTH]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE TABLET [CARDINAL HEALTH]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE BESYLATE TABLET [CARDINAL HEALTH]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMLODIPINE BESYLATE TABLET [CARDINAL HEALTH]	2

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Legacy Pharmaceutical Packaging, LLC	215ef2cb-d5b6-43d5-bbd5-195ec57cde2b	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078552 application number: ANDA078552
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Epic Pharma, LLC	090f3e51-8129-4b5d-97f9-ab410e14df2d	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078552 application number: ANDA078552
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	d17ef907-7719-4246-8ade-b67afdfaf787	2024-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078552 application number: ANDA078552
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	186b6149-9610-4380-9bf2-941646069276	2023-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078552 application number: ANDA078552

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-4331-0	55154433100	10 BLISTER PACK in 1 BAG (55154-4331-0) > 1 TABLET in 1 BLISTER PACK	10 blister pack	2014-01-10	0000-00-00	No	No	Current