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 10 of 13 · 251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
application number: ANDA078414
unii: 864V2Q084H
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
application number: ANDA078414
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

Reported adverse events (FAERS/openFDA)#

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