NDC 57664-569 - Amlodipine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 57664-569
Package NDCs from labels: 57664-569-99, 57664-569-88, 57664-569-13, 57664-569-18
Manufacturer: CARACO PHARMACEUTICAL LABORATORIES, LTD.
Effective date: 2008-12-15
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Amlodipine - CARACO PHARMACEUTICAL LABORATORIES, LTD.	CARACO PHARMACEUTICAL LABORATORIES, LTD.	2008-12-15	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57664-569-13	Amlodipine	500 in 1 BOTTLE	TABLET	500	1
57664-569-18	Amlodipine	1000 in 1 BOTTLE	TABLET	1000	1
57664-569-88	Amlodipine	100 in 1 BOTTLE	TABLET	100	1
57664-569-99	Amlodipine	90 in 1 BOTTLE	TABLET	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57664-569	AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1	4 package rows	20090320_b52e2905-f906-4c46-bb24-2c7754c5d75b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-569-13	EA - Each	57664-569	16785f0f-d993-40b4-86a5-5ada750be530	1	2013-02-13
57664-569-18	EA - Each	57664-569	5df3b1d9-e39c-4fb8-af53-d9f8d8a869a4	1	2013-02-13
57664-569-99	EA - Each	57664-569	a04536fe-5362-4bc9-b359-6b1d07454578	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Amlodipine besylate	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1
Amlodipine	ACTIVE MOIETY	1J444QC288	AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1
butylated hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1
dibasic calcium phosphate	INACTIVE INGREDIENT		AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1
microcrystalline cellulose	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	1
sodium starch glycolate	INACTIVE INGREDIENT		AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	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 4 of 7 · 124 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Quallent Pharmaceuticals Health LLC	c262dedb-1d13-4447-9355-f11e1dbbfb4d	2025-10-13	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	6cf5ece4-4d4e-478e-be8f-bd198c6edc5d	2025-09-29	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	3ce6978a-6ab3-33a9-e063-6294a90a24a1	2025-08-21	Warnings, Adverse reactions	Exact identifier rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	Direct_Rx	0c7d1f99-dfe0-7041-e063-6294a90a9705	2025-07-11	Warnings, Adverse reactions	Exact identifier rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	NuCare Pharmaceuticals,Inc.	2437a130-d544-6db4-e063-6394a90a0d4d	2025-06-13	Warnings, Adverse reactions	Exact identifier rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	921096ab-589a-4821-8d91-a6319f4a559a	2025-04-09	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	dc2107cd-edfa-44a6-b139-edee6ccf47ce	2025-04-08	Warnings, Adverse reactions	Exact identifier rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	00a037f6-b17f-4d21-9a9a-0e682f68d483	2025-04-02	Warnings, Adverse reactions	Exact identifier rxcui: 308136
Amlodipine Besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	313fe7ba-2fbd-bb4d-e063-6294a90a3749	2025-03-26	Warnings, Adverse reactions	Exact identifier rxcui: 197361
AMLODIPINE BESYLATE 2.5 mg	AMLODIPINE BESYLATE	Proficient Rx LP	6313edc5-d2d5-44a1-a06f-7f7829c870d2	2025-02-01	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	Redpharm Drug	fc61eee9-ee15-9078-e053-6394a90a22f4	2025-01-23	Warnings, Adverse reactions	Exact identifier rxcui: 197361
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	DIRECT RX	b8b9a3cd-c4e7-dfeb-e053-2a95a90aa719	2025-01-17	Warnings, Adverse reactions	Exact identifier rxcui: 308136
Amlodipine Besylate	AMLODIPINE BESYLATE	NCS HealthCare of KY, LLC dba Vangard Labs	47f228e9-4a34-4d14-988d-b06af90124b9	2025-01-16	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135
AMLODIPINE BESYLATE 10 mg	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	1871ddaf-ed2c-c3ce-e063-6394a90a1bee	2024-12-20	Warnings, Adverse reactions	Exact identifier rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	Quality Care Products, LLC	a75e4797-6b7f-4366-9105-79d6877adac5	2024-12-19	Warnings, Adverse reactions	Exact identifier rxcui: 197361
Amlodipine Besylate	AMLODIPINE BESYLATE	Quality Care Products, LLC	6b7c18ef-3a85-4ae3-9135-7ac30a0dde08	2024-12-17	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308135
amlodipine besylate	AMLODIPINE BESYLATE	Mylan Pharmaceuticals Inc.	180ee374-24f2-4b9c-9d54-8815f2b1dc9b	2024-11-28	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	Zydus Lifesciences Limited	cacb3551-c579-41cb-bed6-4b4d8b0644fc	2024-11-25		Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	f18148f9-42b2-43dc-9cf8-212d9121dc5f	2024-11-01	Warnings, Adverse reactions	Exact identifier rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	Zydus Pharmaceuticals USA Inc.	fda0739d-b355-478c-acae-8f773a3ec4b3	2024-10-18	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135

Reported adverse events (FAERS/openFDA)#

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