FDA.reportPublic FDA data

NDC 48433-308-01 - 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
48433-308
Requested NDC
48433-308-01
Package NDCs from labels
48433-308-01, 48433-308-10
Manufacturer
Safecor Health, LLC
Effective date
2013-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amlodipine Besylate - Safecor Health, LLCSafecor Health, LLC2013-01-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [SAFECOR HEALTH, LLC]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [SAFECOR HEALTH, LLC]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [SAFECOR HEALTH, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [SAFECOR HEALTH, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [SAFECOR HEALTH, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [SAFECOR HEALTH, LLC]1

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 13 of 13 · 251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILGlenmark Pharmaceuticals Inc., USA2edf43fb-0755-4ffb-bc38-75a4e24325882021-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylate and Atorvastatin calciumAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMDr. Reddy's Laboratories Incabee4a34-89cc-d886-192c-32582ab8f0242021-02-16Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDETeva Pharmaceuticals USA, Inc.5c128ef2-60a6-40f3-b37f-ee139fe279872021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
MEDULLOSSEINUM PLEXARNICA MONTANA, CALCAREA PHOSPHORICA, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, MEDULLOSSEINUM, PULSATILLA, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALESeroyal USA22b7eafe-ef76-0677-e054-00144ff88e882020-10-09WarningsExact identifier
unii: L11K75P92J
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LP9f327d08-7661-4088-b554-2f9a99a113e72020-10-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATECipla USA Inc.0c8d6b2f-3e4a-47a2-80e2-a34dcb3375552020-09-09Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEProficient Rx LP410aa0a5-43cf-455c-b51d-7dfbc24eee322020-02-01Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
311b627b-b77d-44bd-ba8a-d59eed27dede790129ef-6a1b-45cb-8b02-25fa8a40c2ba2019-11-22Warnings, Adverse reactionsExact identifier
spl set id: 790129ef-6a1b-45cb-8b02-25fa8a40c2ba
NorvascAMLODIPINE BESYLATEPFIZER LABORATORIES DIV PFIZER INCabd6a2ca-40c2-485c-bc53-db1c652505ed2019-01-15Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINEMylan Pharmaceuticals Inc.ca60a4d5-ace7-4889-94ee-e2265fd638112018-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC17e6d552-7528-4597-9498-104cb04f32e72017-10-25Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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