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 10 of 12 · 233 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILAmneal Pharmaceuticals NY LLC02f9b562-6f7f-4783-bb0d-67c318073e1c2024-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC132c078d-7d31-a6f2-e063-6294a90af0952024-03-08Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEBryant Ranch Prepack52daa759-3327-461a-8cfc-3c6253df91ec2024-03-05Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATETeva Pharmaceuticals, Inc.47edc328-2444-4ca1-a5c1-7c83141e105c2024-03-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepackb404a550-0df4-404a-8d10-c35e197ca3992024-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepack44dc874b-4377-46eb-ae32-8d84c9c4d4ae2024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEBryant Ranch Prepack498a9b21-34b9-4373-930b-5ed43201a3452024-01-09Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEBryant Ranch Prepacke8958997-f098-44ce-8c21-b7064d1a962e2024-01-09Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions55bfd9ea-b474-4863-8fae-1b720d91034c2024-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINELupin Pharmaceuticals, Inc.a97fefa6-99e6-4eb7-9393-ab2252a2c7d82023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine, Valsartan and HydrochlorothiazideAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe2023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and ValsartanAMLODIPINE AND VALSARTANLupin Pharmaceuticals, Inc.35086164-bf92-4b3c-9845-f8cd7464c7d62023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepack900024f4-23d6-4505-81db-4f643e12858c2023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions5c50c3fe-afe5-459e-95c0-c9af4cbb69092023-11-13Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions89d8d490-3a9c-40f2-86b7-94b5101dd09a2023-10-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions4512feee-a09d-4244-bc03-c43193e53a0e2023-09-20Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsf77db79c-c998-4b63-9984-4cf245f188a72023-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCd830173d-7676-4490-ab3d-d3515df9ad2e2023-09-07Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC5dfcba1f-91c4-4ca5-8a98-fc4fdb2f7ee12023-09-07Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions69a887ab-95cd-4b81-80ee-02e20eebf65b2023-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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