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 1 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	5af8493b-2b73-859c-e063-6394a90a4620	2026-09-08	Warnings, Adverse reactions	Exact identifier rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	GSMS, Incorporated	9c0f83f4-06ad-4bb1-a8e3-dcac43b840cf	2026-09-01	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	NCS HealthCare of KY, LLC dba Vangard Labs	6efc0ef6-0424-44fc-a9ea-eb30c3b83239	2026-09-01	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	QPharma, Inc.	5866d1ee-631d-d09e-e063-6294a90abe01	2026-08-20	Warnings, Adverse reactions	Exact identifier rxcui: 197361
Amlodipine Besylate	AMLODIPINE BESYLATE	Redpharm Drug	58d2fbed-3904-3e31-e063-6294a90af21d	2026-08-12	Warnings, Adverse reactions	Exact identifier rxcui: 197361
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Redpharm Drug	58336a97-807a-2859-e063-6294a90ad338	2026-08-04	Warnings, Adverse reactions	Exact identifier rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	58a67272-c4c7-4e2c-85a5-9d39034d12c3	2026-07-27	Warnings, Adverse reactions	Exact identifier rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	Major Pharmaceuticals	edf9b22c-e37e-4b4e-8a64-20bb036c7d2d	2026-07-27	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135
AMLODIPINE BESYLATE 2.5 mg	AMLODIPINE BESYLATE	PD-Rx Pharmaceuticals, Inc.	1080fcea-a5da-499d-a855-690c13559071	2026-07-17	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	NuCare Pharmaceuticals, Inc.	4926f00c-ee19-3e10-e054-00144ff88e88	2026-07-17	Warnings, Adverse reactions	Exact identifier rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	REMEDYREPACK INC.	4ad016ec-e158-4325-9f45-4460cf78dd98	2026-07-16	Warnings, Adverse reactions	Exact identifier rxcui: 308136
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	REMEDYREPACK INC.	d09173a1-5e3c-4c86-8c7c-15238925ef50	2026-07-01	Warnings, Adverse reactions	Exact identifier rxcui: 197361
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	REMEDYREPACK INC.	a6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb55	2026-06-24	Warnings, Adverse reactions	Exact identifier rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	Unit Dose Solutions, Inc.	5467eee5-1519-7859-e063-6294a90afed1	2026-06-16	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	Safecor Health LLC	572bc798-c3d9-4fe2-98be-8e1913bda8f3	2026-06-12	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	China Resources Saike Pharmaceutical Co., Ltd.	3518853a-4c5b-4161-a178-8da7f656f009	2026-06-08	Warnings, Adverse reactions	Exact identifier rxcui: 197361 rxcui: 308136 rxcui: 308135
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	61cb7f91-d1f6-40bd-98a3-c461098a20d9	2026-06-01	Warnings, Adverse reactions	Exact identifier rxcui: 308136
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Bryant Ranch Prepack	f546047f-1cc6-4bbe-a67b-b5c9815b89af	2026-05-22	Warnings, Adverse reactions	Exact identifier rxcui: 197361
Amlodipine Besylate	AMLODIPINE BESYLATE	ST. MARY'S MEDICAL PARK PHARMACY	b2d5cccd-e5ff-2909-e053-2a95a90a9773	2026-05-22	Warnings, Adverse reactions	Exact identifier rxcui: 308135
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Bryant Ranch Prepack	215e0890-0484-45e8-a731-aea53821ad8e	2026-05-19	Warnings, Adverse reactions	Exact identifier rxcui: 308135

Reported adverse events (FAERS/openFDA)#

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