Sulindac

Product NDC
53808-0303
11-digit product format
538080303
Labeler code
53808
Product ID
53808-0303_3f0ef949-f3ea-4ff8-877a-c412ae2e175e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULINDAC
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA073262
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
2017-12-31
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
53808-0303-12019-10-21C16284748780-1956f9ecf-dfc2-621f-e053-dbdaa90a74adSULINDAC TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0303-1Sulindac30 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
POVIDONEINACTIVE INGREDIENTFZ989GH94ESULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSULINDAC 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
53808-0303SULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100611_b5b9be81-f0b8-4ee2-bcfd-38fbe3805c06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198239sulindac 200 MG Oral TabletPSNb5b9be81-f0b8-4ee2-bcfd-38fbe3805c061
198239sulindac 200 MG Oral TabletSCDb5b9be81-f0b8-4ee2-bcfd-38fbe3805c061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0303-15380803030130 in 1 BLISTER PACKHistorical