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 3 of 13 · 251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine BesylateAMLODIPINE BESYLATECardinal Health 107, LLCa74239bf-4684-424c-ba4e-6087e363265b2026-04-09Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAmneal Pharmaceuticals NY LLC856a8cdc-57cc-4355-966d-986bbc5fa6e62026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEOxford Pharmaceuticals, LLC6f20efca-943b-4bc2-a157-0931bd4d45852026-03-28Warnings, Adverse reactionsExact identifier
application number: ANDA078414
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.5f7a4bd1-8083-46ca-95f2-e8c476b5367c2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepackbed1710f-edd9-488d-855b-603d50ee212c2026-03-20Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ff807933-7433-4f8c-9d09-02a57e51d0fc2026-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepackba6f6ab5-b65a-4486-b994-2d8bbbe650af2026-03-20Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepack5d7ca186-f22b-465f-913b-c020240b2c662026-03-20Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepack50112e22-5a69-47c9-90cd-82bbacae74182026-03-20Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepack9654e50b-811a-4c89-b1ab-f48418b204c12026-03-20Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepackf16e04b5-57b9-49cc-811b-07d85ccb5d9f2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATELegacy Pharmaceutical Packaging, LLC2cdd0da9-eea6-45e0-b0b7-35413a168a4f2026-03-03Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATELegacy Pharmaceutical Packaging, LLC215ef2cb-d5b6-43d5-bbd5-195ec57cde2b2026-03-03Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAurobindo Pharma Limitedb6f298ba-2d7e-4a3c-9edb-8b60aba716d62026-03-03Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.b25681a9-7b0e-40f9-844e-ec4842e3713c2026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.1df35c9b-0cd8-41f4-b9d4-8f51ba57b3e02026-02-26Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.a6635bb3-b8d5-4046-ac56-27af9bac877e2026-02-26Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.aec7618e-c9da-431f-8b6a-14aa399242f62026-02-25Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATE 10 mgAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.ea9f44a1-96cf-496a-8c07-18d8de27e5122026-02-25Warnings, Adverse reactionsExact identifier
application number: ANDA078414
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack4e6bf47a-ee8a-4083-8cce-a6a25260d3fb2026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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