SULINDAC

Product NDC
0904-7335
11-digit product format
009047335
Labeler code
0904
Product ID
0904-7335_ff631d39-5057-492d-90a4-32e4999b06de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulindac
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA072051
Marketing category
ANDA
Marketing start
2023-07-27
Marketing end
2026-07-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SULINDAC

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
0904-7335-60SULINDAC100 in 1 BOTTLE, PLASTICTABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7335-60EA - Each0904-7335f0d64b87-311b-4f36-8283-91b8b1b2b51112024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7335SULINDAC TABLET [MAJOR PHARMACEUTICALS]3Current NDC, 1 package rows20250227_41c7882e-530a-4ac1-8de4-8d1e7b391467.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
0904-7335-6000904733560100 TABLET in 1 BOTTLE, PLASTIC (0904-7335-60) 100 tablet2023-07-272026-07-31NoNoHistorical