FDA.reportPublic FDA data

NDC 0832-0044-89 - 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
0832-0044
Requested NDC
0832-0044-89
Package NDCs from labels
0832-0044-09, 0832-0044-10, 0832-0044-89, 0832-0044-01
Manufacturer
Upsher-Smith Laboratories, LLC
Effective date
2020-01-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
amlodipine besylate - Upsher-Smith Laboratories, LLCUpsher-Smith Laboratories, LLC2020-01-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
amlodipine besylateACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [UPSHER-SMITH LABORATORIES, INC.]11
amlodipineACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [UPSHER-SMITH LABORATORIES, INC.]11
calcium phosphate, dibasic, dihydrateINACTIVE INGREDIENTO7TSZ97GEPAMLODIPINE BESYLATE TABLET [UPSHER-SMITH LABORATORIES, INC.]11
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [UPSHER-SMITH LABORATORIES, INC.]11
magnesium stearateINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [UPSHER-SMITH LABORATORIES, INC.]11
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [UPSHER-SMITH LABORATORIES, INC.]11

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 12 · 233 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals, Inc.01139e81-a4fa-4e13-acdf-c75c79a1aa9c2026-02-23Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.1ff04bd2-9926-48a4-9afc-eab0789dba012026-02-23Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
ExforgeAMLODIPINE BESYLATE AND VALSARTANNovartis Pharmaceuticals Corporationd0caec89-96ec-411d-a933-63eda74a6da72026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepack043c4742-081d-4bc4-bf27-dad92bb2dfbc2026-02-12Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.ea774c36-e970-4d9c-9487-6cc57741fec52026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC4a2bba2d-9b7a-f43a-e063-6294a90af80e2026-02-06Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack5813e6b6-f524-4fba-99ba-9f4e365bf5232026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepackc56a384c-b250-4a43-99ce-ddd88376c8172026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions3b13554a-0f63-4238-8f55-a1400c847c9f2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49e5eeaa-7506-f42a-e063-6294a90a28642026-02-03WarningsExact identifier
unii: O7TSZ97GEP
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f94296-3e74-1828-e063-6394a90a97d52026-02-03WarningsExact identifier
unii: O7TSZ97GEP
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f942e6-ceef-5505-e063-6394a90a113f2026-02-03WarningsExact identifier
unii: O7TSZ97GEP
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.cb87f119-1598-405f-b627-eec749c8d42c2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC41496b0d-f1ca-4e9d-e063-6394a90aec1d2026-01-29Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILA-S Medication Solutions350c7317-a92d-4bcb-973f-19d6de87ed832026-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATE 5 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC49104797-8202-1376-e063-6294a90adb382026-01-23Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC3ab4ad3d-7795-058a-e063-6294a90abc862026-01-23Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.743ae641-14e1-456b-80e6-c6f7d621e9692026-01-16Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.6e038d92-09f3-4517-947e-146d007114b82026-01-14Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILAvKARE1b30c3fe-5c84-0d42-e063-6394a90a81d82026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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