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 11 of 13 · 250 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepackb404a550-0df4-404a-8d10-c35e197ca3992024-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepack44dc874b-4377-46eb-ae32-8d84c9c4d4ae2024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEBryant Ranch Prepack498a9b21-34b9-4373-930b-5ed43201a3452024-01-09Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEBryant Ranch Prepacke8958997-f098-44ce-8c21-b7064d1a962e2024-01-09Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions55bfd9ea-b474-4863-8fae-1b720d91034c2024-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINELupin Pharmaceuticals, Inc.a97fefa6-99e6-4eb7-9393-ab2252a2c7d82023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine, Valsartan and HydrochlorothiazideAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe2023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and ValsartanAMLODIPINE AND VALSARTANLupin Pharmaceuticals, Inc.35086164-bf92-4b3c-9845-f8cd7464c7d62023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepack900024f4-23d6-4505-81db-4f643e12858c2023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions5c50c3fe-afe5-459e-95c0-c9af4cbb69092023-11-13Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions89d8d490-3a9c-40f2-86b7-94b5101dd09a2023-10-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions4512feee-a09d-4244-bc03-c43193e53a0e2023-09-20Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsf77db79c-c998-4b63-9984-4cf245f188a72023-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCd830173d-7676-4490-ab3d-d3515df9ad2e2023-09-07Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC5dfcba1f-91c4-4ca5-8a98-fc4fdb2f7ee12023-09-07Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions69a887ab-95cd-4b81-80ee-02e20eebf65b2023-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AzorAMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMILCosette Pharmaceuticals, Inc.c5535406-b63b-49aa-88b9-169aaf0ed08e2023-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
TribenzorOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDECosette Pharmaceuticals, Inc.2f56d0bc-236b-41a0-9fc0-21cdfea8d8902023-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LPced6d26e-8c54-4808-88b6-446344f4acd02023-06-01Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC186b6149-9610-4380-9bf2-9416460692762023-05-04Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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