amlodipine besylate

Product NDC: 52605-043
Requested package NDC: 52605-043-19
11-digit product format: 526050043
Labeler code: 52605
Product ID: 52605-043_83e3e459-c254-45e3-a5ac-2e717e08c348
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine besylate
Dosage form: TABLET
Route: ORAL
Labeler: POLYGEN PHARMACEUTICALS INC.
Application: ANDA207821
Marketing category: ANDA
Marketing start: 2016-07-11
Substance: AMLODIPINE BESYLATE
Active strength: 10 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	52605-043	52605-043-19	D	Discontinued by firm		2026-09-14

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	52605-043	52605-043-19	I	Inactivated by FDA		excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

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

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
A207821-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2016-07-11
A207821-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-11
A207821-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207821-001	AB
A207821-002	AB
A207821-003	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 · 129 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	A207821-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2016-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207821-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207821-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207821-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2016-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207821-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207821-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207821-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2016-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207821-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207821-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207821-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2016-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207821-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207821-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207821-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2016-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207821-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207821-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207821-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2016-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207821-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207821-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207821-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2016-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207821-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207821-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207821-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2016-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207821-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207821-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207821-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2016-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207821-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207821-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207821-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2016-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207821-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207821-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207821-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2016-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207821-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207821-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207821-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2016-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207821-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207821-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207821-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2016-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207821-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207821-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207821-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2016-07-11	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207821-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207821-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207821-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207821-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207821-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207821-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207821-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207821-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207821-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207821-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207821-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207821-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207821-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207821-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207821-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207821-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207821-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207821-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207821-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207821-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207821-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207821-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207821-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207821-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207821-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207821-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207821-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207821-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207821-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207821-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207821-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207821-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207821-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207821-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207821-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207821-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207821-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207821-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207821-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207821-001	AB	1	`301d65b070ca…`

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, Related label table
NDC	Effective	Related label
52605-043-10	2020-10-26	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral use Initial U.S. Approval: 1992
52605-043-19	2020-10-26	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral use Initial U.S. Approval: 1992
52605-043-10	2020-01-31	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral use Initial U.S. Approval: 1992
52605-043-19	2020-01-31	These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52605-043-10	amlodipine besylate	1000 in 1 BOTTLE	TABLET	1000		8
52605-043-19	amlodipine besylate	90 in 1 BOTTLE	TABLET	90		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52605-043	AMLODIPINE BESYLATE TABLET [POLYGEN PHARMACEUTICALS INC.]	8	Current NDC, Legacy NDC, 2 package rows	20221130_f5fbfd12-a600-482d-a306-5d6c09ae4210.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
308135	amLODIPine besylate 10 MG Oral Tablet	PSN	f5fbfd12-a600-482d-a306-5d6c09ae4210	8
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	f5fbfd12-a600-482d-a306-5d6c09ae4210	8
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	f5fbfd12-a600-482d-a306-5d6c09ae4210	8
308135	amlodipine 10 MG Oral Tablet	SCD	f5fbfd12-a600-482d-a306-5d6c09ae4210	8
308136	amlodipine 2.5 MG Oral Tablet	SCD	f5fbfd12-a600-482d-a306-5d6c09ae4210	8
197361	amlodipine 5 MG Oral Tablet	SCD	f5fbfd12-a600-482d-a306-5d6c09ae4210	8
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	f5fbfd12-a600-482d-a306-5d6c09ae4210	8
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	f5fbfd12-a600-482d-a306-5d6c09ae4210	8
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	f5fbfd12-a600-482d-a306-5d6c09ae4210	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52605-043-19	52605004319	90 TABLET in 1 BOTTLE (52605-043-19)	90 tablet	2016-07-11	0000-00-00	No	No	Current