FDA.reportPublic FDA data

cilostazol

Product NDC
60505-2522
11-digit product format
605052522
Labeler code
60505
Product ID
60505-2522_855689c6-1a9b-a366-dcc4-e6a1c04ff25a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cilostazol
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA077030
Marketing category
ANDA
Marketing start
2011-10-18
Substance
CILOSTAZOL
Active strength
100 mg/1
Pharmacologic classes
Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
cilostazol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CILOSTAZOL100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7Z035406B
Rxcui242461, 242462

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c114def4-591e-cde9-1a9f-29af28d4c1eaProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-2522-1cilostazol60 in 1 BOTTLETABLET6010
60505-2522-3cilostazol30 in 1 BOTTLETABLET3010
60505-2522-8cilostazol1000 in 1 BOTTLETABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2522-1EA - Each60505-252224549779-c4a7-46de-bf81-85315da9476a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cilostazolACTIVE INGREDIENTN7Z035406BCILOSTAZOL TABLET [APOTEX CORP.]5
cilostazolACTIVE MOIETYN7Z035406BCILOSTAZOL TABLET [APOTEX CORP.]5
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CILOSTAZOL TABLET [APOTEX CORP.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30CILOSTAZOL TABLET [APOTEX CORP.]5
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CILOSTAZOL TABLET [APOTEX CORP.]5
starch, cornINACTIVE INGREDIENTO8232NY3SJCILOSTAZOL TABLET [APOTEX CORP.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2522CILOSTAZOL TABLET [APOTEX CORP.]9Current NDC, Legacy NDC, 3 package rows20240922_ceac1ae3-c343-28ca-c083-b748d21a15e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242461cilostazol 100 MG Oral TabletPSNceac1ae3-c343-28ca-c083-b748d21a15e610
242462cilostazol 50 MG Oral TabletPSNceac1ae3-c343-28ca-c083-b748d21a15e610
242461cilostazol 100 MG Oral TabletSCDceac1ae3-c343-28ca-c083-b748d21a15e610
242462cilostazol 50 MG Oral TabletSCDceac1ae3-c343-28ca-c083-b748d21a15e610
242461cilostazol 100 MG Oral TabletPSNaec462c8-e225-f520-cae5-80049151c0ff8
242462cilostazol 50 MG Oral TabletPSNaec462c8-e225-f520-cae5-80049151c0ff8
242461cilostazol 100 MG Oral TabletSCDaec462c8-e225-f520-cae5-80049151c0ff8
242462cilostazol 50 MG Oral TabletSCDaec462c8-e225-f520-cae5-80049151c0ff8
242461cilostazol 100 MG Oral TabletPSNdc7c2c25-36a1-e3fd-e053-2995a90adabc3
242461cilostazol 100 MG Oral TabletSCDdc7c2c25-36a1-e3fd-e053-2995a90adabc3
242461cilostazol 100 MG Oral TabletPSN15ead884-bd4f-7f4b-e063-6394a90a8f811
242461cilostazol 100 MG Oral TabletSCD15ead884-bd4f-7f4b-e063-6394a90a8f811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-2522-16050525220160 TABLET in 1 BOTTLE (60505-2522-1) 60 tablet2011-10-180000-00-00NoNoCurrent
60505-2522-36050525220330 TABLET in 1 BOTTLE (60505-2522-3) 30 tablet2011-10-180000-00-00NoNoCurrent
60505-2522-8605052522081000 TABLET in 1 BOTTLE (60505-2522-8) 1000 tablet2011-10-180000-00-00NoNoCurrent