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 5 of 12 · 233 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine BesylateAMLODIPINE BESYLATEAvKAREfeb9438a-9cbc-4855-e053-6394a90af15e2026-01-13Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATE 10 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC47e494d2-8971-3f8f-e063-6394a90adb202026-01-08Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEPD-Rx Pharmaceuticals, Inc.e01efe66-2f31-4261-92ca-0b41f27104da2026-01-07Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Olmesartan medoxomil, amlodipine and hydrochlorothiazideOLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDECamber Pharmaceuticals, Inc.45e975ff-07b1-411a-96ee-a011d1619b1e2026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE and OLMESARTAN medoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILMacleods Pharmaceuticals Limitedc86a3c45-c906-46c9-9f7b-6c3d89bbe48f2026-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLCfa153720-b24c-60d0-e053-6294a90a97d52026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLCf2b56630-4e3a-6f9c-e053-2a95a90a46502026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATENorthwind Health Company, LLCf2b8274b-d849-6793-e053-2a95a90aa0e82026-01-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATENorthwind Health Company, LLCf32bb322-68d7-a4ca-e053-2995a90aa7b02026-01-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATENorthwind Health Company, LLC0c5784b9-5542-144f-e063-6394a90a7ebc2026-01-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATENorthwind Health Company, LLC03fe9ad2-3a1a-78db-e063-6294a90a2ed32026-01-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
amlodipine and valsartanAMLODIPINE AND VALSARTANMacleods Pharmaceuticals Limited5dfadaf0-c333-4b79-9a97-e42f77505c402025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATENorthwind Health Company, LLC0de6a6d0-a114-e114-e063-6394a90a34dd2025-12-26Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLC106c08c2-90eb-6bc0-e063-6294a90a5a232025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions2b0e3752-c54e-4c50-9640-1a6fefa6dec52025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEEpic Pharma, LLC090f3e51-8129-4b5d-97f9-ab410e14df2d2025-12-17Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions7a75935a-31af-4571-b7d9-8c297a635b572025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Exforge HCTAMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDENovartis Pharmaceuticals Corporation18d7820d-471f-4ee2-9ec6-25d8d27c77de2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAscend Laboratories, LLC2b0bcb95-dc85-46f7-8b69-ca55cd58b30e2025-12-10Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEQPharma Inc3f74ed2b-4712-4026-ac2c-9239a211dde32025-12-05Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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