FDA.reportPublic FDA data

SULINDAC

Product NDC
53489-478
11-digit product format
534890478
Labeler code
53489
Product ID
53489-478_2524fd49-5789-e388-e063-6394a90a2c9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulindac
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA072050
Marketing category
ANDA
Marketing start
2009-09-04
Substance
SULINDAC
Active strength
150 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
SULINDAC150 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
53489-478-01SULINDAC100 in 1 BOTTLE, PLASTICTABLET10016
53489-478-02SULINDAC50 in 1 BOTTLE, PLASTICTABLET5016
53489-478-03SULINDAC250 in 1 BOTTLE, PLASTICTABLET25016
53489-478-05SULINDAC500 in 1 BOTTLE, PLASTICTABLET50016
53489-478-06SULINDAC60 in 1 BOTTLE, PLASTICTABLET6016
53489-478-10SULINDAC1000 in 1 BOTTLE, PLASTICTABLET100016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-478-01EA - Each53489-478e8bbcb46-edf6-4184-975f-20a9d192a4f412012-07-24
53489-478-05EA - Each53489-478f7314153-eda9-47f5-81d8-958bc8457c8712012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-478SULINDAC 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
198238sulindac 150 MG Oral TabletPSNeb7acb87-6565-4524-a91a-02064ea8bd1a22
198238sulindac 150 MG Oral TabletSCDeb7acb87-6565-4524-a91a-02064ea8bd1a22
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53489-478-0153489047801100 TABLET in 1 BOTTLE, PLASTIC (53489-478-01) 100 tablet2009-09-040000-00-00NoNoCurrent
53489-478-025348904780250 TABLET in 1 BOTTLE, PLASTIC (53489-478-02) 50 tablet2009-09-040000-00-00NoNoCurrent
53489-478-0353489047803250 TABLET in 1 BOTTLE, PLASTIC (53489-478-03) 250 tablet2009-09-040000-00-00NoNoCurrent
53489-478-0553489047805500 TABLET in 1 BOTTLE, PLASTIC (53489-478-05) 500 tablet2009-09-040000-00-00NoNoCurrent
53489-478-065348904780660 TABLET in 1 BOTTLE, PLASTIC (53489-478-06) 60 tablet2009-09-040000-00-00NoNoCurrent
53489-478-10534890478101000 TABLET in 1 BOTTLE, PLASTIC (53489-478-10) 1000 tablet2009-09-040000-00-00NoNoCurrent