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 6 of 12 · 233 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMLODIPINE BESYLATEAMLODIPINE BESYLATECipla USA Inc.5409b296-3bed-47cd-abba-9fe6f6833af62025-12-03Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylate and Olmesartan medoxomilAMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMILAjanta Pharma USA Inc.69fa6293-b10a-4473-ab9b-1bd53f099bdd2025-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDEOLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDEMicro Labs Limited9fb71df8-f70f-47dc-9465-8d8748261caf2025-11-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepackbe709711-e7ee-403f-ad43-873761deee372025-10-30Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions3ad66075-0875-4703-9d21-a424b5ab892a2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEBoswell Pharmacy Services LLC d/b/a BPS Wholesale41af64c4-b788-d827-e063-6394a90a91572025-10-21Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsc9693ad5-0fa6-4796-b20b-2021d589a1322025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEPD-Rx Pharmaceuticals, Inc.47114f60-4151-43d4-ac2d-adc49492a6792025-10-15Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEPD-Rx Pharmaceuticals, Inc.ac0dd8fb-ebe1-4d02-bd0d-4f979c6e36082025-10-15Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.02e233c4-48d1-456d-8fc8-f99a06ef854a2025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEQuallent Pharmaceuticals Health LLCc262dedb-1d13-4447-9355-f11e1dbbfb4d2025-10-13Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7b5eb6bd-e953-429e-9280-07da4f7d7f472025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDELupin Pharmaceuticals, Inc.968c611b-43a7-40f0-9ed3-aa67ee88364b2025-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEBryant Ranch Prepack6cf5ece4-4d4e-478e-be8f-bd198c6edc5d2025-09-29Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC3ce6978a-6ab3-33a9-e063-6294a90a24a12025-08-21Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylate and Olmesartran medoxomilAMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMILAlembic Pharmaceuticals Inc.1eb78d80-701d-4766-98c3-feee6790de1a2025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Olmesartan medoxomil Amlodipine and HydrochlorothiazideOLMESARTAN MEDOXOMIL AMLODIPINE AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited52c013e1-8c31-4bed-9241-e7845873ebe82025-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEDirect_Rx0c7d1f99-dfe0-7041-e063-6294a90a97052025-07-11Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
olmesartan medoxomil and amlodipine besylate and hydrochlorothiazideOLMESARTAN MEDOXOMIL AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDESlate Run Pharmaceuticals, LLCa469adff-25a6-4983-b471-60924d920a862025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATENuCare Pharmaceuticals,Inc.2437a130-d544-6db4-e063-6394a90a0d4d2025-06-13Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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