Sulindac

Product NDC
53808-0814
11-digit product format
538080814
Labeler code
53808
Product ID
53808-0814_123676fd-fb30-4627-b6e8-def7d4e41931
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulindac
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA072711
Marketing category
ANDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
SULINDAC
Active strength
200 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
53808-0814-12020-01-31C16284748780-19d75b9d0-d2a0-f424-e053-dadaa90a57ceSulindac Tablets USP, 150 mg and 200 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0814-1Sulindac30 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
POVIDONE K30INACTIVE INGREDIENTU725QWY32XSULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0814SULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140415_df5f89a8-70b3-40bc-8a05-8daa8c881d06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198239sulindac 200 MG Oral TabletPSNdf5f89a8-70b3-40bc-8a05-8daa8c881d061
198239sulindac 200 MG Oral TabletSCDdf5f89a8-70b3-40bc-8a05-8daa8c881d061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0814-15380808140130 in 1 BLISTER PACKHistorical