Amlodipine Besylate

Product NDC: 72189-689
Requested package NDC: 72189-689-90
11-digit product format: 721890689
Labeler code: 72189
Product ID: 72189-689_5c29aadb-b8fd-83c8-e063-6394a90a7a16
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine Besylate
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA203245
Marketing category: ANDA
Marketing start: 2026-09-23
Substance: AMLODIPINE BESYLATE
Active strength: 2.5 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: 2027-12-31
Current FDA listing: Yes

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
A203245-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21
A203245-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21
A203245-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203245-001	AB
A203245-002	AB
A203245-003	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	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`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	A203245-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203245-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203245-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203245-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203245-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203245-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203245-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203245-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203245-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203245-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203245-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203245-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203245-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203245-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203245-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203245-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203245-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203245-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203245-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203245-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203245-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203245-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203245-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203245-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203245-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203245-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203245-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203245-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203245-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203245-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203245-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203245-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203245-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203245-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203245-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203245-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203245-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203245-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203245-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203245-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Amlodipine Besylate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMLODIPINE BESYLATE	2.5 mg/1

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine Besylate	AMLODIPINE BESYLATE	Redpharm Drug	58d2fbed-3904-3e31-e063-6294a90af21d	2026-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	ST. MARY'S MEDICAL PARK PHARMACY	b2d5cccd-e5ff-2909-e053-2a95a90a9773	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	988e5acb-356e-4116-b6db-ab8468ed7234	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	743ae641-14e1-456b-80e6-c6f7d621e969	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Northwind Health Company, LLC	0de6a6d0-a114-e114-e063-6394a90a34dd	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	41af64c4-b788-d827-e063-6394a90a9157	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Direct_Rx	0c7d1f99-dfe0-7041-e063-6294a90a9705	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Redpharm Drug	fc61eee9-ee15-9078-e053-6394a90a22f4	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Quality Care Products, LLC	a75e4797-6b7f-4366-9105-79d6877adac5	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	699d3ba2-a342-4e3d-b8ad-c14e0df64dfe	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	da4e36d3-1ddc-4350-9a00-86975e523f75	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	b1151904-5085-49bd-94ec-cb2894f4eb10	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	NuCare Pharmaceuticals,Inc.	b4cc6d7e-923b-e81c-e053-2995a90a0731	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Direct_Rx	094498f2-11d9-2a05-e063-6294a90ab2e1	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	5a67bbdc-ac1f-4778-bbdc-929df140b7f5	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	52daa759-3327-461a-8cfc-3c6253df91ec	2024-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	5c50c3fe-afe5-459e-95c0-c9af4cbb6909	2023-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Unichem Pharmaceuticals (USA), Inc.	a516b336-8f60-4b86-8921-c7d6c07629f2	2022-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	5f3ac64c-6e33-40c1-9b8e-dc0c8dd7e8d6	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	c2c51ec3-ffb0-4240-b048-a8e424775a76	2021-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203245 application number: ANDA203245

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

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
104416	amlodipine besylate	amlodipine besylate	PIN Active

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72189-689-90	72189068990	90 TABLET in 1 BOTTLE (72189-689-90)	90 tablet	2026-09-23	No	No	Current