FDA.reportPublic FDA data

NDC 63672-0046-3 - Amlodipine Besylate

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
63672-0046
Requested NDC
63672-0046-3
Package NDCs from labels
63672-0046-3
Manufacturer
Synthon Pharmaceuticals, Inc.
Effective date
2008-01-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amlodipine Besylate TabletsSynthon Pharmaceuticals, Inc.2008-01-23HUMAN PRESCRIPTION DRUG LABELING
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63672-0046-3Amlodipine Besylate90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63672-0046AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [SYNTHON PHARMACEUTICALS, INC.]11 package rows20080130_6E9A6C82-9F25-4C71-B09A-929BD5D7B1CF.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63672-0046-3EA - Each63672-0046627162b8-efab-4148-9a9e-775ad343e34d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Amlodipine besylateACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [SYNTHON PHARMACEUTICALS, INC.]1
AmlodipineACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [SYNTHON PHARMACEUTICALS, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [SYNTHON PHARMACEUTICALS, INC.]1
microcrystalline celluloseINACTIVE INGREDIENTAMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [SYNTHON PHARMACEUTICALS, INC.]1
sodium starch glycolateINACTIVE INGREDIENTAMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [SYNTHON PHARMACEUTICALS, INC.]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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine BesylateAMLODIPINE BESYLATECoupler LLC5af8493b-2b73-859c-e063-6394a90a46202026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 308135
Amlodipine BesylateAMLODIPINE BESYLATEGSMS, Incorporated9c0f83f4-06ad-4bb1-a8e3-dcac43b840cf2026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308135
Amlodipine BesylateAMLODIPINE BESYLATENCS HealthCare of KY, LLC dba Vangard Labs6efc0ef6-0424-44fc-a9ea-eb30c3b832392026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
Amlodipine BesylateAMLODIPINE BESYLATEQPharma, Inc.5866d1ee-631d-d09e-e063-6294a90abe012026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 197361
Amlodipine BesylateAMLODIPINE BESYLATERedpharm Drug58d2fbed-3904-3e31-e063-6294a90af21d2026-08-12Warnings, Adverse reactionsExact identifier
rxcui: 197361
AMLODIPINE BESYLATEAMLODIPINE BESYLATERedpharm Drug58336a97-807a-2859-e063-6294a90ad3382026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 308135
Amlodipine BesylateAMLODIPINE BESYLATEREMEDYREPACK INC.58a67272-c4c7-4e2c-85a5-9d39034d12c32026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 308135
Amlodipine BesylateAMLODIPINE BESYLATEMajor Pharmaceuticalsedf9b22c-e37e-4b4e-8a64-20bb036c7d2d2026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEPD-Rx Pharmaceuticals, Inc.1080fcea-a5da-499d-a855-690c135590712026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
AMLODIPINE BESYLATEAMLODIPINE BESYLATENuCare Pharmaceuticals, Inc.4926f00c-ee19-3e10-e054-00144ff88e882026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 308135
Amlodipine BesylateAMLODIPINE BESYLATEREMEDYREPACK INC.4ad016ec-e158-4325-9f45-4460cf78dd982026-07-16Warnings, Adverse reactionsExact identifier
rxcui: 308136
AMLODIPINE BESYLATEAMLODIPINE BESYLATEREMEDYREPACK INC.d09173a1-5e3c-4c86-8c7c-15238925ef502026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 197361
AMLODIPINE BESYLATEAMLODIPINE BESYLATEREMEDYREPACK INC.a6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb552026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 308135
Amlodipine BesylateAMLODIPINE BESYLATEUnit Dose Solutions, Inc.5467eee5-1519-7859-e063-6294a90afed12026-06-16Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308135
Amlodipine BesylateAMLODIPINE BESYLATESafecor Health LLC572bc798-c3d9-4fe2-98be-8e1913bda8f32026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
Amlodipine BesylateAMLODIPINE BESYLATEChina Resources Saike Pharmaceutical Co., Ltd.3518853a-4c5b-4161-a178-8da7f656f0092026-06-08Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LP61cb7f91-d1f6-40bd-98a3-c461098a20d92026-06-01Warnings, Adverse reactionsExact identifier
rxcui: 308136
AMLODIPINE BESYLATEAMLODIPINE BESYLATEBryant Ranch Prepackf546047f-1cc6-4bbe-a67b-b5c9815b89af2026-05-22Warnings, Adverse reactionsExact identifier
rxcui: 197361
Amlodipine BesylateAMLODIPINE BESYLATEST. MARY'S MEDICAL PARK PHARMACYb2d5cccd-e5ff-2909-e053-2a95a90a97732026-05-22Warnings, Adverse reactionsExact identifier
rxcui: 308135
AMLODIPINE BESYLATEAMLODIPINE BESYLATEBryant Ranch Prepack215e0890-0484-45e8-a731-aea53821ad8e2026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 308135

Reported adverse events (FAERS/openFDA)#

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