FDA.reportPublic FDA data

NDC 59762-2010-01 - 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
59762-2010
Requested NDC
59762-2010-01
Package NDCs from labels
59762-2010-9, 59762-2010-3, 59762-2010-1, 59762-2010-01
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2024-11-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
amlodipine besylate - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2024-11-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-2010-1amlodipine besylate1000 in 1 BOTTLETABLET100032
59762-2010-3amlodipine besylate300 in 1 BOTTLETABLET30032
59762-2010-9amlodipine besylate90 in 1 BOTTLETABLET9032

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-2010AMLODIPINE BESYLATE TABLET [MYLAN PHARMACEUTICALS INC.]31Current NDC, Legacy NDC, 3 package rows20250502_180ee374-24f2-4b9c-9d54-8815f2b1dc9b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-2010-1EA - Each59762-201002138dd6-d473-4892-b0ae-8c78a8d4437f12019-07-02
59762-2010-3EA - Each59762-201051b3ff67-f1e1-4b68-8f57-97363b78090212019-07-02
59762-2010-9EA - Each59762-2010baddac96-f6f2-46c8-a173-93e23006f4f312019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [GREENSTONE LLC]19
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [GREENSTONE LLC]19
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [GREENSTONE LLC]19
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [GREENSTONE LLC]19
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [GREENSTONE LLC]19
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [GREENSTONE LLC]19

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 4 of 13 · 250 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals, Inc.01139e81-a4fa-4e13-acdf-c75c79a1aa9c2026-02-23Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.1ff04bd2-9926-48a4-9afc-eab0789dba012026-02-23Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
ExforgeAMLODIPINE BESYLATE AND VALSARTANNovartis Pharmaceuticals Corporationd0caec89-96ec-411d-a933-63eda74a6da72026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepack043c4742-081d-4bc4-bf27-dad92bb2dfbc2026-02-12Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.ea774c36-e970-4d9c-9487-6cc57741fec52026-02-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC4a2bba2d-9b7a-f43a-e063-6294a90af80e2026-02-06Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack5813e6b6-f524-4fba-99ba-9f4e365bf5232026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepackc56a384c-b250-4a43-99ce-ddd88376c8172026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions3b13554a-0f63-4238-8f55-a1400c847c9f2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEREMEDYREPACK INC.cb87f119-1598-405f-b627-eec749c8d42c2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC41496b0d-f1ca-4e9d-e063-6394a90aec1d2026-01-29Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILA-S Medication Solutions350c7317-a92d-4bcb-973f-19d6de87ed832026-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATE 5 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC49104797-8202-1376-e063-6294a90adb382026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC3ab4ad3d-7795-058a-e063-6294a90abc862026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.743ae641-14e1-456b-80e6-c6f7d621e9692026-01-16Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.6e038d92-09f3-4517-947e-146d007114b82026-01-14Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILAvKARE1b30c3fe-5c84-0d42-e063-6394a90a81d82026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAvKAREfeb9438a-9cbc-4855-e053-6394a90af15e2026-01-13Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
Pyrogenium Combination 9239PYROGENIUM COMBINATIONProfessional Complementary Health Formulas8b869987-bfd2-4451-a2a8-ce3a92e201f22026-01-08WarningsExact identifier
unii: L11K75P92J
Pneumo Drops 5018PNEUMO DROPSProfessional Complementary Health Formulasea6d0286-db1c-48c0-83fd-c18fa8f8629f2026-01-08WarningsExact identifier
unii: L11K75P92J

Reported adverse events (FAERS/openFDA)#

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