Amlodipine Besylate

Product NDC: 50090-2581
11-digit product format: 500902581
Labeler code: 50090
Product ID: 50090-2581_ac5a7515-6873-4ec9-ac86-a6b3cc95b7ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine besylate
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA078925
Marketing category: ANDA
Marketing start: 2010-10-20
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

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
A078925-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04
A078925-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04
A078925-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078925-001	AB
A078925-002	AB
A078925-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A078925-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2009-05-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078925-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2009-05-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078925-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2009-05-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A078925-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078925-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078925-003	AB	1	`a50c72e98297…`

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 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	58a67272-c4c7-4e2c-85a5-9d39034d12c3	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	4ad016ec-e158-4325-9f45-4460cf78dd98	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Unit Dose Solutions, Inc.	5467eee5-1519-7859-e063-6294a90afed1	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	61cb7f91-d1f6-40bd-98a3-c461098a20d9	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	NCS HealthCare of KY, LLC dba Vangard Labs	6efc0ef6-0424-44fc-a9ea-eb30c3b83239	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Coupler LLC	2904c6e1-2c51-8035-e063-6294a90aa04b	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	72dafc2f-5266-442b-914a-61d1ef1f7ab8	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	d2f66b58-78ec-456b-8397-2120a223827c	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	cd305e6e-9107-4d25-9918-8d0d9b9ba1ca	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	50204e86-a345-4d2f-b62f-a548787e197f	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals, Inc.	01139e81-a4fa-4e13-acdf-c75c79a1aa9c	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	1ff04bd2-9926-48a4-9afc-eab0789dba01	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	204f27e9-5041-4677-b313-866ca69abad9	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	6e038d92-09f3-4517-947e-146d007114b8	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Northwind Health Company, LLC	f2b8274b-d849-6793-e053-2a95a90aa0e8	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Northwind Health Company, LLC	f32bb322-68d7-a4ca-e053-2995a90aa7b0	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	Ascend Laboratories, LLC	2b0bcb95-dc85-46f7-8b69-ca55cd58b30e	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	QPharma Inc	3f74ed2b-4712-4026-ac2c-9239a211dde3	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	47114f60-4151-43d4-ac2d-adc49492a679	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925
Amlodipine Besylate	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	ac0dd8fb-ebe1-4d02-bd0d-4f979c6e3608	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078925 application number: ANDA078925

Additional Listing Data#

Finished product: Yes
Brand name base: Amlodipine Besylate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMLODIPINE BESYLATE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
864V2Q084H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197361	Internal RxNorm lookup
308135	Internal RxNorm lookup
308136	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
921096ab-589a-4821-8d91-a6319f4a559a	Available on FDA.report

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
50090-2581-0	2023-02-07	C162847	48780-1	f386c649-e5bd-0266-e053-dadaa90a7c1a	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 administration Initial U.S. Approval: 1992
50090-2581-1	2023-02-07	C162847	48780-1	f386c649-e5bd-0266-e053-dadaa90a7c1a	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 administration Initial U.S. Approval: 1992
50090-2581-0	2023-01-30	C162847	48780-1	f386c649-e5bd-0266-e053-dadaa90a7c1a	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 administration Initial U.S. Approval: 1992
50090-2581-1	2023-01-30	C162847	48780-1	f386c649-e5bd-0266-e053-dadaa90a7c1a	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 administration Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-2581-0	Amlodipine Besylate	30 in 1 BOTTLE	TABLET	30	35
50090-2581-1	Amlodipine Besylate	90 in 1 BOTTLE	TABLET	90	35
50090-2581-2	Amlodipine Besylate	100 in 1 BOTTLE	TABLET	100	35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-2581-0	EA - Each	50090-2581	b6c28d62-c31c-4046-8ac9-49f518e6bcac	1	2019-04-11
50090-2581-1	EA - Each	50090-2581	c6cd2b45-dbcb-4425-a669-59b70252b0a6	1	2018-11-06
50090-2581-2	EA - Each	50090-2581	5e5b87f4-6b59-4943-96cf-09e1969b453b	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-2581	AMLODIPINE BESYLATE TABLET [A-S MEDICATION SOLUTIONS]	35	Current NDC, Legacy NDC, 3 package rows	20250417_921096ab-589a-4821-8d91-a6319f4a559a.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	921096ab-589a-4821-8d91-a6319f4a559a	35
308136	amLODIPine besylate 2.5 MG Oral Tablet	PSN	921096ab-589a-4821-8d91-a6319f4a559a	35
197361	amLODIPine besylate 5 MG Oral Tablet	PSN	921096ab-589a-4821-8d91-a6319f4a559a	35
308135	amlodipine 10 MG Oral Tablet	SCD	921096ab-589a-4821-8d91-a6319f4a559a	35
308136	amlodipine 2.5 MG Oral Tablet	SCD	921096ab-589a-4821-8d91-a6319f4a559a	35
197361	amlodipine 5 MG Oral Tablet	SCD	921096ab-589a-4821-8d91-a6319f4a559a	35
308135	amlodipine (as amlodipine besylate) 10 MG Oral Tablet	SY	921096ab-589a-4821-8d91-a6319f4a559a	35
308136	amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet	SY	921096ab-589a-4821-8d91-a6319f4a559a	35
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	921096ab-589a-4821-8d91-a6319f4a559a	35

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-2581-0	50090258100	30 TABLET in 1 BOTTLE (50090-2581-0)	30 tablet	2016-11-08	0000-00-00	No	No	Current
50090-2581-1	50090258101	90 TABLET in 1 BOTTLE (50090-2581-1)	90 tablet	2016-11-01	0000-00-00	No	No	Current
50090-2581-2	50090258102	100 TABLET in 1 BOTTLE (50090-2581-2)	100 tablet	2023-07-13		No	No	Current