SULINDAC

Product NDC
53808-0302
11-digit product format
538080302
Labeler code
53808
Product ID
53808-0302_377ae7e3-f630-4ebb-b85c-312b614c8631
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulindac
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA072051
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
SULINDAC
Active strength
200 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c7c8244c-3606-b814-8453-06ab13fc5907Product name220201015

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0302-12020-01-31C16284748780-19d75b9d0-a912-f424-e053-dadaa90a57ceSULINDAC TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0302-1SULINDAC30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULINDACACTIVE INGREDIENT184SNS8VUHSULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
sulindacACTIVE MOIETY184SNS8VUHSULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0302SULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100611_87449866-cf27-4c2f-b57b-a967408e0d63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198239sulindac 200 MG Oral TabletPSN87449866-cf27-4c2f-b57b-a967408e0d631
198239sulindac 200 MG Oral TabletSCD87449866-cf27-4c2f-b57b-a967408e0d631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0302-15380803020130 in 1 BLISTER PACKHistorical