Amlodipine Besylate

Product NDC: 43353-691
11-digit product format: 433530691
Labeler code: 43353
Product ID: 43353-691_1fb58ec3-f97b-443f-ada2-a8d4edaedef8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine besylate
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA078414
Marketing category: ANDA
Marketing start: 2010-04-07
Marketing end: 0000-00-00
Substance: AMLODIPINE BESYLATE
Active strength: 10 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#

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-691		D	Discontinued by firm	2026-08-03
excluded package	package	43353-691	43353-691-30	D	Discontinued by firm	2026-08-03
excluded package	package	43353-691	43353-691-45	D	Discontinued by firm	2026-08-03
excluded package	package	43353-691	43353-691-60	D	Discontinued by firm	2026-08-03

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-691-30	EA - Each	43353-691	415a89a3-8c9c-482b-8523-61c1125bfd32	1	2014-09-03
43353-691-60	EA - Each	43353-691	c978aa06-e1e0-4d31-8c69-0e1a22148b32	1	2017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-691	AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC	20171026_6e83de08-b0f6-492a-a2db-e8d33a7a28aa.zip

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
43353-691-30	43353069130	30 TABLET in 1 BOTTLE, PLASTIC (43353-691-30)	30 tablet	2010-12-22	0000-00-00	No	No	Current
43353-691-45	43353069145	45 TABLET in 1 BOTTLE, PLASTIC (43353-691-45)	45 tablet	2015-09-18	0000-00-00	No	No	Current
43353-691-60	43353069160	90 TABLET in 1 BOTTLE, PLASTIC (43353-691-60)	90 tablet	2015-12-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine Besylate	Aphena Pharma Solutions - Tennessee, LLC	2017-10-25	HUMAN PRESCRIPTION DRUG LABEL	2