FDA.reportPublic FDA data

SULINDAC

Product NDC
53489-479
11-digit product format
534890479
Labeler code
53489
Product ID
53489-479_2524fd49-5789-e388-e063-6394a90a2c9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulindac
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA072051
Marketing category
ANDA
Marketing start
2009-09-04
Substance
SULINDAC
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SULINDAC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULINDAC200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii184SNS8VUH
Rxcui198238, 198239

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53489-479-01SULINDAC100 in 1 BOTTLE, PLASTICTABLET10016
53489-479-02SULINDAC50 in 1 BOTTLE, PLASTICTABLET5016
53489-479-03SULINDAC250 in 1 BOTTLE, PLASTICTABLET25016
53489-479-05SULINDAC500 in 1 BOTTLE, PLASTICTABLET50016
53489-479-06SULINDAC60 in 1 BOTTLE, PLASTICTABLET6016
53489-479-10SULINDAC1000 in 1 BOTTLE, PLASTICTABLET100016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-479-01EA - Each53489-479e125341c-1c43-4855-85b9-4bbcf9318ae712012-07-24
53489-479-05EA - Each53489-479d8fd85c4-c449-4f68-8296-afa16cb8dcca12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sulindacACTIVE INGREDIENT184SNS8VUHSULINDAC TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
sulindacACTIVE MOIETY184SNS8VUHSULINDAC TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61USULINDAC TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
magnesium stearateINACTIVE INGREDIENT70097M6I30SULINDAC TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
starch, cornINACTIVE INGREDIENTO8232NY3SJSULINDAC TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
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
53489-479SULINDAC TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]16Current NDC, Legacy NDC, 6 package rows20241025_a47e4259-d44b-4b7b-b517-841cb6840982.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198239sulindac 200 MG Oral TabletPSN1fffe88d-50c8-45cf-ac7c-a62b665c89a822
198239sulindac 200 MG Oral TabletSCD1fffe88d-50c8-45cf-ac7c-a62b665c89a822
198238sulindac 150 MG Oral TabletPSNa47e4259-d44b-4b7b-b517-841cb684098216
198239sulindac 200 MG Oral TabletPSNa47e4259-d44b-4b7b-b517-841cb684098216
198238sulindac 150 MG Oral TabletSCDa47e4259-d44b-4b7b-b517-841cb684098216
198239sulindac 200 MG Oral TabletSCDa47e4259-d44b-4b7b-b517-841cb684098216
198239sulindac 200 MG Oral TabletPSNf4985b1b-7e2c-4911-897a-94c337794bab11
198239sulindac 200 MG Oral TabletSCDf4985b1b-7e2c-4911-897a-94c337794bab11
198238sulindac 150 MG Oral TabletPSN41c7882e-530a-4ac1-8de4-8d1e7b3914676
198239sulindac 200 MG Oral TabletPSN41c7882e-530a-4ac1-8de4-8d1e7b3914676
198238sulindac 150 MG Oral TabletSCD41c7882e-530a-4ac1-8de4-8d1e7b3914676
198239sulindac 200 MG Oral TabletSCD41c7882e-530a-4ac1-8de4-8d1e7b3914676
198239sulindac 200 MG Oral TabletPSN6db52fd3-172f-47ab-8aa6-4f3d031c6b254
198239sulindac 200 MG Oral TabletSCD6db52fd3-172f-47ab-8aa6-4f3d031c6b254
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53489-479-0153489047901100 TABLET in 1 BOTTLE, PLASTIC (53489-479-01) 100 tablet2009-09-040000-00-00NoNoCurrent
53489-479-025348904790250 TABLET in 1 BOTTLE, PLASTIC (53489-479-02) 50 tablet2009-09-040000-00-00NoNoCurrent
53489-479-0353489047903250 TABLET in 1 BOTTLE, PLASTIC (53489-479-03) 250 tablet2009-09-040000-00-00NoNoCurrent
53489-479-0553489047905500 TABLET in 1 BOTTLE, PLASTIC (53489-479-05) 500 tablet2009-09-040000-00-00NoNoCurrent
53489-479-065348904790660 TABLET in 1 BOTTLE, PLASTIC (53489-479-06) 60 tablet2009-09-040000-00-00NoNoCurrent
53489-479-10534890479101000 TABLET in 1 BOTTLE, PLASTIC (53489-479-10) 1000 tablet2009-09-040000-00-00NoNoCurrent