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 2 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	Coupler LLC	2904c6e1-2c51-8035-e063-6294a90aa04b	2026-05-13	Warnings, Adverse reactions	Exact identifier rxcui: 308136
Amlodipine Besylate	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	5a0b3dd4-91f5-4173-a992-e91b1cac6a18	2026-05-05	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	Bryant Ranch Prepack	72dafc2f-5266-442b-914a-61d1ef1f7ab8	2026-04-29	Warnings, Adverse reactions	Exact identifier rxcui: 308136
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	d2f66b58-78ec-456b-8397-2120a223827c	2026-04-28	Warnings, Adverse reactions	Exact identifier rxcui: 308136
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	cd305e6e-9107-4d25-9918-8d0d9b9ba1ca	2026-04-24	Warnings, Adverse reactions	Exact identifier rxcui: 308136
Amlodipine Besylate	AMLODIPINE BESYLATE	A-S Medication Solutions	50204e86-a345-4d2f-b62f-a548787e197f	2026-04-24	Warnings, Adverse reactions	Exact identifier rxcui: 308136
Amlodipine Besylate	AMLODIPINE BESYLATE	Lupin Pharmaceuticals, Inc.	003dd1ec-16f8-4f96-b6a8-c4689d35892a	2026-04-20	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	988e5acb-356e-4116-b6db-ab8468ed7234	2026-04-13	Warnings, Adverse reactions	Exact identifier rxcui: 197361
Amlodipine Besylate	AMLODIPINE BESYLATE	Cardinal Health 107, LLC	a74239bf-4684-424c-ba4e-6087e363265b	2026-04-09	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135
AMLODIPINE BESYLATE 2.5 mg	AMLODIPINE BESYLATE	Oxford Pharmaceuticals, LLC	6f20efca-943b-4bc2-a157-0931bd4d4585	2026-03-28	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	Legacy Pharmaceutical Packaging, LLC	2cdd0da9-eea6-45e0-b0b7-35413a168a4f	2026-03-03	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308135
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Legacy Pharmaceutical Packaging, LLC	215ef2cb-d5b6-43d5-bbd5-195ec57cde2b	2026-03-03	Warnings, Adverse reactions	Exact identifier rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	Aurobindo Pharma Limited	b6f298ba-2d7e-4a3c-9edb-8b60aba716d6	2026-03-03	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	1df35c9b-0cd8-41f4-b9d4-8f51ba57b3e0	2026-02-26	Warnings, Adverse reactions	Exact identifier rxcui: 308136
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	a6635bb3-b8d5-4046-ac56-27af9bac877e	2026-02-26	Warnings, Adverse reactions	Exact identifier rxcui: 308135
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	aec7618e-c9da-431f-8b6a-14aa399242f6	2026-02-25	Warnings, Adverse reactions	Exact identifier rxcui: 197361
AMLODIPINE BESYLATE 10 mg	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	ea9f44a1-96cf-496a-8c07-18d8de27e512	2026-02-25	Warnings, Adverse reactions	Exact identifier rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals, Inc.	01139e81-a4fa-4e13-acdf-c75c79a1aa9c	2026-02-23	Warnings, Adverse reactions	Exact identifier rxcui: 197361
Amlodipine Besylate	AMLODIPINE BESYLATE	Preferred Pharmaceuticals Inc.	1ff04bd2-9926-48a4-9afc-eab0789dba01	2026-02-23	Warnings, Adverse reactions	Exact identifier rxcui: 308136
Amlodipine Besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	4a2bba2d-9b7a-f43a-e063-6294a90af80e	2026-02-06	Warnings, Adverse reactions	Exact identifier rxcui: 308135

Reported adverse events (FAERS/openFDA)#

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