FDA.reportPublic FDA data

cilostazol

Product NDC
50268-176
11-digit product format
502680176
Labeler code
50268
Product ID
50268-176_47bc4cad-6c05-e6d6-e063-6294a90a5c2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cilostazol
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA077030
Marketing category
ANDA
Marketing start
2016-10-18
Substance
CILOSTAZOL
Active strength
50 mg/1
Pharmacologic classes
Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
cilostazol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CILOSTAZOL50 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
50268-176-11cilostazol1 in 1 BLISTER PACKTABLET18
50268-176-15cilostazol50 in 1 BOX, UNIT-DOSETABLET508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-176-11EA - Each50268-17651e79974-a1a8-44ee-9f4f-6e3537b1925c12016-12-07
50268-176-15EA - Each50268-176248551ae-9746-40f2-a8d4-0acd184e02a612016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-176CILOSTAZOL TABLET [AVPAK]7Current NDC, Legacy NDC, 2 package rows20240110_aec462c8-e225-f520-cae5-80049151c0ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-176-11502680176111 in 1 BLISTER PACKHistorical
50268-176-155026801761550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-176-15) / 1 TABLET in 1 BLISTER PACK (50268-176-11) 50 blister pack2016-10-180000-00-00NoNoCurrent