FDA.reportPublic FDA data

NDC 50268-083-11 - 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
50268-083
Requested NDC
50268-083-11
Package NDCs from labels
50268-083-11, 50268-083-15
Manufacturer
AvPAK
Effective date
2020-10-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMLODIPINE BESYLATE - AvPAKAvPAK2020-10-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-083-11EA - Each50268-083aa75e726-1bbd-44a7-beca-fb5131e96a3712015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [AVPAK]2
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [AVPAK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [AVPAK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [AVPAK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [AVPAK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [AVPAK]2

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 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.0f253cac-67ac-4b03-b1a8-f2c345938dda2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.dc206611-5188-40a6-b025-61db41f68a5a2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.2542895b-c8f8-4f21-9e12-f5a7fe17f9052026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATECoupler LLC5af8493b-2b73-859c-e063-6394a90a46202026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINApotex Corp.4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b032026-09-03Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEGSMS, Incorporated9c0f83f4-06ad-4bb1-a8e3-dcac43b840cf2026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308135
unii: 864V2Q084H
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
unii: 864V2Q084H
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEREMEDYREPACK INC.57ffeef7-bfa8-4f92-aadc-23cd000226072026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEQPharma, Inc.5866d1ee-631d-d09e-e063-6294a90abe012026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAmerican Health Packaging79f41cd2-6d58-4b03-8b0c-ca91398bc1a92026-08-17Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATERedpharm Drug58d2fbed-3904-3e31-e063-6294a90af21d2026-08-12Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATERedpharm Drug58336a97-807a-2859-e063-6294a90ad3382026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEREMEDYREPACK INC.58a67272-c4c7-4e2c-85a5-9d39034d12c32026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEMajor Pharmaceuticalsedf9b22c-e37e-4b4e-8a64-20bb036c7d2d2026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
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
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATENuCare Pharmaceuticals, Inc.4926f00c-ee19-3e10-e054-00144ff88e882026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEREMEDYREPACK INC.4ad016ec-e158-4325-9f45-4460cf78dd982026-07-16Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
WIDAPLIKTELMISARTAN, AMLODIPINE AND INDAPAMIDEAzurity Pharmaceuticals, Inc.a30ff81d-420b-40ea-83d8-670260a93fff2026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEREMEDYREPACK INC.d09173a1-5e3c-4c86-8c7c-15238925ef502026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.27b0c628-820a-48bf-a411-86c0ebd4cc8d2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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