FDA.reportPublic FDA data

Cilostazol

Product NDC
70436-157
11-digit product format
704360157
Labeler code
70436
Product ID
70436-157_45be0b2e-7ae1-42d2-e063-6394a90a1da6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cilostazol
Dosage form
TABLET
Route
ORAL
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA077208
Marketing category
ANDA
Marketing start
2018-01-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70436-157-062023-01-31C16284748780-1f386c649-fca7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CILOSTAZOL TABLETS safely and effectively. See full prescribing information for CILOSTAZOL TABLETS. CILOSTAZOL tablets, for oral use. Initial U.S. Approval: 1999
70436-157-062023-01-30C16284748780-1f386c649-fca7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CILOSTAZOL TABLETS safely and effectively. See full prescribing information for CILOSTAZOL TABLETS. CILOSTAZOL tablets, for oral use. Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70436-157-06Cilostazol60 in 1 BOTTLETABLET605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-157-06EA - Each70436-15772bdd8bd-a76a-42f1-a86b-9a74cdb04c0f12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-157CILOSTAZOL TABLET [SLATE RUN PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 1 package rows20240427_db0278e9-4ece-4aaf-9216-6bcbec58206a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242461cilostazol 100 MG Oral TabletPSNdb0278e9-4ece-4aaf-9216-6bcbec58206a5
242462cilostazol 50 MG Oral TabletPSNdb0278e9-4ece-4aaf-9216-6bcbec58206a5
242461cilostazol 100 MG Oral TabletSCDdb0278e9-4ece-4aaf-9216-6bcbec58206a5
242462cilostazol 50 MG Oral TabletSCDdb0278e9-4ece-4aaf-9216-6bcbec58206a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70436-157-067043601570660 TABLET in 1 BOTTLE (70436-157-06) 60 tablet2021-04-160000-00-00NoNoCurrent