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 8 of 13 · 250 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINAlembic Pharmaceuticals Limitedecab983e-6ed8-4440-b7b4-7ac4bf39b26c2025-05-23Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDEStrides Pharma Science Limited9b76e441-e6a5-4036-8276-b7788ade5c442025-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions921096ab-589a-4821-8d91-a6319f4a559a2025-04-09Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutionsdc2107cd-edfa-44a6-b139-edee6ccf47ce2025-04-08Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions00a037f6-b17f-4d21-9a9a-0e682f68d4832025-04-02Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILCamber Pharmaceuticals, Inc.99865c67-5475-4e60-98d5-a8fa850fe9ba2025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC313fe7ba-2fbd-bb4d-e063-6294a90a37492025-03-26Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions1dd12925-ede8-4ad5-9309-d8c79da1cebf2025-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEProficient Rx LP6313edc5-d2d5-44a1-a06f-7f7829c870d22025-02-01Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATERedpharm Drugfc61eee9-ee15-9078-e053-6394a90a22f42025-01-23Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEDIRECT RXb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7192025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATENCS HealthCare of KY, LLC dba Vangard Labs47f228e9-4a34-4d14-988d-b06af90124b92025-01-16Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.7c75fa72-9b0f-44bf-a745-dfa647ed1e782025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
amlodipine,valsartan and hydrochlorothiazideAMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited1ea4f227-b97a-49f1-bbc3-1dede2c1866d2025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE AND OLMESARTAN MEDOXOMILMicro Labs Limited7fcf6a87-7b3e-4cef-8c47-c8a008cfea822025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATE 10 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC1871ddaf-ed2c-c3ce-e063-6394a90a1bee2024-12-20Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEQuality Care Products, LLCa75e4797-6b7f-4366-9105-79d6877adac52024-12-19Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEQuality Care Products, LLC6b7c18ef-3a85-4ae3-9135-7ac30a0dde082024-12-17Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308135
unii: 864V2Q084H
amlodipine besylateAMLODIPINE BESYLATEMylan Pharmaceuticals Inc.180ee374-24f2-4b9c-9d54-8815f2b1dc9b2024-11-28Warnings, Adverse reactionsExact identifier
application number: NDA019787
ndc (package): 59762-2010-3
ndc (package): 59762-2135-9
ndc (package): 59762-2242-9
ndc (package): 59762-2242-3
ndc (package): 59762-2135-1
ndc (package): 59762-2010-1
ndc (package): 59762-2010-9
ndc (product): 59762-2135
ndc (product): 59762-2010
ndc (product): 59762-2242
ndc11 (package): 59762201001
rxcui: 197361
rxcui: 308136
rxcui: 308135
spl id: 4826ff96-be7a-460d-8ec0-d6bd025d1162
spl set id: 180ee374-24f2-4b9c-9d54-8815f2b1dc9b
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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