FDA.reportPublic FDA data

SULINDAC

Product NDC
50090-0529
11-digit product format
500900529
Labeler code
50090
Product ID
50090-0529_4b79e8cf-aa02-4ef9-b1fd-62d80bd37dc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULINDAC
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA072711
Marketing category
ANDA
Marketing start
2010-01-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SULINDAC
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULINDAC200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii184SNS8VUH
Rxcui198239

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
50090-0529-02023-01-30C16284748780-1f386c649-e4f3-0266-e053-dadaa90a7c1aSulindac Tablets USP, 150 mg and 200 mg Rx only
50090-0529-12023-01-30C16284748780-1f386c649-e4f3-0266-e053-dadaa90a7c1aSulindac Tablets USP, 150 mg and 200 mg Rx only
50090-0529-42023-01-30C16284748780-1f386c649-e4f3-0266-e053-dadaa90a7c1aSulindac Tablets USP, 150 mg and 200 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0529-0SULINDAC14 in 1 BOTTLETABLET1416
50090-0529-1SULINDAC30 in 1 BOTTLETABLET3016
50090-0529-4SULINDAC60 in 1 BOTTLETABLET6016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0529-1EA - Each50090-05297781975b-e4e3-4926-bf07-23786d2565e512018-09-05
50090-0529-4EA - Each50090-05291372e2b7-1cf1-4047-b26c-f8ac6bccf7cf12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0529SULINDAC TABLET [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 3 package rows20190125_6041acc2-5e8a-4d3c-bf50-7e9447748e2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198239sulindac 200 MG Oral TabletPSN6041acc2-5e8a-4d3c-bf50-7e9447748e2b16
198239sulindac 200 MG Oral TabletSCD6041acc2-5e8a-4d3c-bf50-7e9447748e2b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0529-05009005290014 in 1 BOTTLEHistorical
50090-0529-15009005290130 TABLET in 1 BOTTLE (50090-0529-1) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-0529-45009005290460 TABLET in 1 BOTTLE (50090-0529-4) 60 tablet2016-06-290000-00-00NoNoCurrent