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 7 of 12 · 233 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.e9ecbadb-c548-6fe5-e053-2a95a90a75772025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepackd058e426-8786-4fd3-a771-992e4558c1352025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILAscend Laboratories, LLCc1204fbe-d086-43cf-bbaa-efec9cd0487c2025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINAlembic Pharmaceuticals Inc.1346631f-e6db-4c5c-a6af-5aa7b80a011d2025-05-23Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINAlembic Pharmaceuticals Limitedecab983e-6ed8-4440-b7b4-7ac4bf39b26c2025-05-23Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDEStrides Pharma Science Limited9b76e441-e6a5-4036-8276-b7788ade5c442025-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions921096ab-589a-4821-8d91-a6319f4a559a2025-04-09Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutionsdc2107cd-edfa-44a6-b139-edee6ccf47ce2025-04-08Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions00a037f6-b17f-4d21-9a9a-0e682f68d4832025-04-02Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILCamber Pharmaceuticals, Inc.99865c67-5475-4e60-98d5-a8fa850fe9ba2025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC313fe7ba-2fbd-bb4d-e063-6294a90a37492025-03-26Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions1dd12925-ede8-4ad5-9309-d8c79da1cebf2025-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEProficient Rx LP6313edc5-d2d5-44a1-a06f-7f7829c870d22025-02-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATERedpharm Drugfc61eee9-ee15-9078-e053-6394a90a22f42025-01-23Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEDIRECT RXb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7192025-01-17Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATENCS HealthCare of KY, LLC dba Vangard Labs47f228e9-4a34-4d14-988d-b06af90124b92025-01-16Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.7c75fa72-9b0f-44bf-a745-dfa647ed1e782025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
amlodipine,valsartan and hydrochlorothiazideAMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited1ea4f227-b97a-49f1-bbc3-1dede2c1866d2025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE AND OLMESARTAN MEDOXOMILMicro Labs Limited7fcf6a87-7b3e-4cef-8c47-c8a008cfea822025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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