cilostazol

Product NDC
71610-813
11-digit product format
716100813
Labeler code
71610
Product ID
71610-813_1547a408-12a9-fadd-e063-6394a90a4ce0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cilostazol
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077030
Marketing category
ANDA
Marketing start
2022-04-12
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

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
71610-813-26cilostazol1200 in 1 BOTTLETABLET12001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-813-26EA - Each71610-813d23251e9-b98b-48be-964e-5d392690252812024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-813CILOSTAZOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 1 package rows20240407_15478d90-312f-014e-e063-6294a90ae838.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242461cilostazol 100 MG Oral TabletPSN15478d90-312f-014e-e063-6294a90ae8381
242461cilostazol 100 MG Oral TabletSCD15478d90-312f-014e-e063-6294a90ae8381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-813-26716100813261200 TABLET in 1 BOTTLE (71610-813-26) 1200 tablet2024-04-03NoNoHistorical