Amlodipine Besylate

Product NDC: 50090-6877
11-digit product format: 500906877
Labeler code: 50090
Product ID: 50090-6877_284221d6-4e43-46b1-9ddf-c6f19bfce2af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine Besylate
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA203245
Marketing category: ANDA
Marketing start: 2019-05-22
Substance: AMLODIPINE BESYLATE
Active strength: 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: 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
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.

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	A203245-001	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2013-10-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203245-002	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-10-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203245-003	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-10-21	`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	A203245-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203245-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A203245-003	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 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	REMEDYREPACK INC.	3e0fbf93-cc64-4fa5-b586-c2020614c884	2025-09-03	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 ndc (product): 50090-6877
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

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	5 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197361	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
699d3ba2-a342-4e3d-b8ad-c14e0df64dfe	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-6877-0	Amlodipine Besylate	90 in 1 BOTTLE	TABLET	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-6877-0	EA - Each	50090-6877	deb70e6b-1cfb-4072-a930-a9531413ef2f	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-6877	AMLODIPINE BESYLATE TABLET [A-S MEDICATION SOLUTIONS]	3	Current NDC, 1 package rows	20241010_699d3ba2-a342-4e3d-b8ad-c14e0df64dfe.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	699d3ba2-a342-4e3d-b8ad-c14e0df64dfe	3
197361	amlodipine 5 MG Oral Tablet	SCD	699d3ba2-a342-4e3d-b8ad-c14e0df64dfe	3
197361	amlodipine (as amlodipine besylate) 5 MG Oral Tablet	SY	699d3ba2-a342-4e3d-b8ad-c14e0df64dfe	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-6877-0	50090687700	90 TABLET in 1 BOTTLE (50090-6877-0)	90 tablet	2023-12-05	No	No	Current