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 9 of 12 · 233 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepackbe69f132-8b77-4590-a688-cb37096494662024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack3de54c49-3590-4a70-9268-fa68e434d9232024-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack30c401b5-decf-4c0c-8180-92a9b3d7d0fb2024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepackc870013c-e823-4233-a803-33a74f3610a82024-06-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and ValsartanAMLODIPINE AND VALSARTANAlembic Pharmaceuticals Inc.6894085d-6076-4e2e-8105-a9bbb0bd93ef2024-06-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAscend Laboratories, LLC3f4703c0-0b9e-41a0-8b70-da26683d9ed22024-06-21Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATENuCare Pharmaceuticals,Inc.9c448d87-294e-3325-e053-2a95a90a22992024-06-20Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEAurobindo Pharma Limited99ed4927-9a34-4e8d-8eea-60b63c867d462024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEDirect_Rx094498f2-11d9-2a05-e063-6294a90ab2e12024-06-13Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions5a67bbdc-ac1f-4778-bbdc-929df140b7f52024-06-10Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATENuCare Pharmaceuticals,Inc.638d86ab-986b-59ed-e053-2a91aa0a98ee2024-06-06Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and valsartanAMLODIPINE AND VALSARTANAurobindo Pharma Limited7fa25f10-29e0-4162-81a8-9d2e03054ded2024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine, Valsartan and HydrochlorothiazideAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limited6fba5243-ee00-4825-a04a-321cb6b49c562024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATENuCare Pharmaceuticals,Inc.ca8c6ca7-79c6-5299-e053-2a95a90a790d2024-05-15Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILAurobindo Pharma Limitedb13a8b46-104e-4b75-8f4a-928d2204eff52024-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepacka6ebafdc-4301-4d6c-b578-b3212648b13a2024-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEBryant Ranch Prepackc3742b31-11f6-4c11-98e3-75916a1982d42024-04-04Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEBryant Ranch Prepackf968393f-47d2-4c16-b34f-93a9d61adb9e2024-04-04Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCd17ef907-7719-4246-8ade-b67afdfaf7872024-03-26Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATE 10 mgAMLODIPINE BESYLATENuCare Pharmaceuticals,Inc.ffe96aa1-db66-33e4-e053-6394a90a7e4e2024-03-26Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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