cilostazol

Product NDC
42291-453
11-digit product format
422910453
Labeler code
42291
Product ID
42291-453_485d4436-cc9f-8ea9-e063-6294a90a53be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cilostazol
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
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
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
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
42291-453-60cilostazol60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-453-60EA - Each42291-4534d05d360-3866-498f-83bc-9db47d9216a212022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-453CILOSTAZOL TABLET [AVKARE]2Current NDC, Legacy NDC, 1 package rows20240110_dc7c2c25-36a1-e3fd-e053-2995a90adabc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242461cilostazol 100 MG Oral TabletPSNdc7c2c25-36a1-e3fd-e053-2995a90adabc3
242461cilostazol 100 MG Oral TabletSCDdc7c2c25-36a1-e3fd-e053-2995a90adabc3
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 startMarketing endSampleExclude flagStatus
42291-453-604229104536060 TABLET in 1 BOTTLE (42291-453-60) 60 tablet2022-04-120000-00-00NoNoCurrent