Amlodipine Besylate

Product NDC: 53808-1029
11-digit product format: 538081029
Labeler code: 53808
Product ID: 53808-1029_76ca1035-dc48-4c4d-90e3-0d1456d0e604
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine besylate
Dosage form: TABLET
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA078414
Marketing category: ANDA
Marketing start: 2014-11-01
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: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	53808-1029		I	Inactivated by FDA		2026-08-03
excluded package	package	53808-1029	53808-1029-1	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 28 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	53808-1029		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-1029	53808-1029-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	53808-1029		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-1029	53808-1029-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	53808-1029		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-1029	53808-1029-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	53808-1029		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-1029	53808-1029-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	53808-1029		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-1029	53808-1029-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	53808-1029		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-1029	53808-1029-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	53808-1029		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-1029	53808-1029-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	53808-1029		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-1029	53808-1029-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	53808-1029		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-1029	53808-1029-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product	53808-1029		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-1029	53808-1029-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	53808-1029		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-1029	53808-1029-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	53808-1029		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-1029	53808-1029-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	53808-1029		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-1029	53808-1029-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	53808-1029		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-1029	53808-1029-1	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078414-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-04-07
A078414-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2010-04-07
A078414-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2010-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078414-001	AB
A078414-002	AB
A078414-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A078414-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078414-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2010-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078414-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2010-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078414-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078414-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2010-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078414-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2010-04-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078414-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078414-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2010-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078414-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2010-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078414-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078414-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2010-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078414-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2010-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078414-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078414-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2010-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078414-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2010-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078414-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078414-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2010-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078414-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2010-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078414-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078414-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2010-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078414-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2010-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078414-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078414-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2010-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078414-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2010-04-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078414-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078414-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2010-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078414-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2010-04-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078414-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078414-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2010-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078414-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2010-04-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078414-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-04-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078414-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2010-04-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078414-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2010-04-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078414-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-04-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078414-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2010-04-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078414-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2010-04-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078414-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-04-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078414-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2010-04-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078414-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2010-04-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078414-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-04-07	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A078414-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078414-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078414-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078414-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078414-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078414-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078414-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078414-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078414-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078414-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078414-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078414-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078414-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078414-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078414-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078414-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078414-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078414-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078414-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078414-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078414-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078414-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078414-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078414-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078414-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078414-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078414-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078414-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078414-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078414-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078414-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078414-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078414-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078414-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078414-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078414-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078414-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078414-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078414-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078414-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMLODIPINE BESYLATE 2.5 mg	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	1080fcea-a5da-499d-a855-690c13559071	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414
AMLODIPINE BESYLATE 2.5 mg	AMLODIPINE BESYLATE	Oxford Pharmaceuticals, LLC	6f20efca-943b-4bc2-a157-0931bd4d4585	2026-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414
AMLODIPINE BESYLATE 10 mg	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	ea9f44a1-96cf-496a-8c07-18d8de27e512	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414
AMLODIPINE BESYLATE 5 mg	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	49104797-8202-1376-e063-6294a90adb38	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414
AMLODIPINE BESYLATE 10 mg	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	47e494d2-8971-3f8f-e063-6394a90adb20	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414
AMLODIPINE BESYLATE 2.5 mg	AMLODIPINE BESYLATE	Proficient Rx LP	6313edc5-d2d5-44a1-a06f-7f7829c870d2	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414
AMLODIPINE BESYLATE 10 mg	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	1871ddaf-ed2c-c3ce-e063-6394a90a1bee	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414
AMLODIPINE BESYLATE 10 mg	AMLODIPINE BESYLATE	NuCare Pharmaceuticals,Inc.	ffe96aa1-db66-33e4-e053-6394a90a7e4e	2024-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414
AMLODIPINE BESYLATE 2.5 mg	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	132c078d-7d31-a6f2-e063-6294a90af095	2024-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414
AMLODIPINE BESYLATE 5 mg	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	b597d1e1-aba1-4272-bed7-4c95e8150d58	2023-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078414 application number: ANDA078414

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
14c2c15b-f823-4ada-a40e-a440544294dc	Product name	1	20221207
a72887ef-d675-499f-af4b-78688f6855cd	Product name	1	20191002
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-1029-1	2020-01-31	C162847	48780-1	9d75b9d1-15f3-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use amlodipine besylate tablets USP safely and effectively. See full prescribing information for amlodipine besylate tablets USP. Amlodipine Besylate Tablets USP for oral administration Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-1029-1	Amlodipine Besylate	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-1029	AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20141219_b3d9dd95-d250-4201-8e95-466fd321c37e.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	b3d9dd95-d250-4201-8e95-466fd321c37e	1
197361	amlodipine 5 MG Oral Tablet	SCD	b3d9dd95-d250-4201-8e95-466fd321c37e	1
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	b3d9dd95-d250-4201-8e95-466fd321c37e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-1029-1	53808102901	30 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine Besylate	State of Florida DOH Central Pharmacy	2014-12-07	HUMAN PRESCRIPTION DRUG LABEL	1