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 8 of 12 · 233 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMLODIPINE BESYLATE 10 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC1871ddaf-ed2c-c3ce-e063-6394a90a1bee2024-12-20Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEQuality Care Products, LLCa75e4797-6b7f-4366-9105-79d6877adac52024-12-19Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEQuality Care Products, LLC6b7c18ef-3a85-4ae3-9135-7ac30a0dde082024-12-17Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
amlodipine besylateAMLODIPINE BESYLATEMylan Pharmaceuticals Inc.180ee374-24f2-4b9c-9d54-8815f2b1dc9b2024-11-28Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEZydus Lifesciences Limitedcacb3551-c579-41cb-bed6-4b4d8b0644fc2024-11-25Exact identifier
unii: 864V2Q084H
Amlodipine and atorvastatinAMLODIPINE AND ATORVASTATINMylan Pharmaceuticals Inc.4be76756-4114-4d50-a36c-fd410f6c773d2024-11-11Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepack49ec5ac8-a626-4ab2-9799-8a138920201e2024-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LPf18148f9-42b2-43dc-9cf8-212d9121dc5f2024-11-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsb6eb5283-8e07-47b8-b440-fe72859d8bcc2024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEZydus Pharmaceuticals USA Inc.fda0739d-b355-478c-acae-8f773a3ec4b32024-10-18Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions91e11ca6-05fb-47be-bd40-f8649a35d47d2024-10-15Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions3bd019d3-b58c-44ab-9190-606a0af5e9b62024-10-14Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions699d3ba2-a342-4e3d-b8ad-c14e0df64dfe2024-10-09Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutionsda4e36d3-1ddc-4350-9a00-86975e523f752024-10-09Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEBryant Ranch Prepack49d69d27-2a75-4a07-bfb9-24f8af8531382024-10-07Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDERising Pharma Holdings, Inc.03b175fc-d430-490d-b7ac-9f7a2cb1dd8b2024-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEBryant Ranch Prepackb1151904-5085-49bd-94ec-cb2894f4eb102024-08-22Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE AND OLMESARTAN MEDOXOMILBryant Ranch Prepackf16c4254-fb35-408e-9419-e17d684ea5ac2024-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepack204592ba-a68f-452a-9987-1b33b7b6c4d52024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEBryant Ranch Prepack1b449c22-0181-4a50-94b3-26139b90b9782024-08-07Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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