Sulindac

Product NDC
54738-903
11-digit product format
547380903
Labeler code
54738
Product ID
54738-903_034a7f71-4589-441c-b585-d57be8942b80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulindac
Dosage form
TABLET
Route
ORAL
Labeler
Richmond Pharmaceuticals
Application
ANDA072051
Marketing category
ANDA
Marketing start
2009-09-04
Marketing end
0000-00-00
Substance
SULINDAC
Active strength
200 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
54738-903-012019-10-29C16284748780-1960f7f55-d19c-8e05-e053-dbdaa90a074aSULINDAC TABLETS USP
54738-903-022019-10-29C16284748780-1960f7f55-d19c-8e05-e053-dbdaa90a074aSULINDAC TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54738-903-01Sulindac100 in 1 BOTTLE, PLASTICTABLET1002
54738-903-02Sulindac500 in 1 BOTTLE, PLASTICTABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54738-903-01EA - Each54738-9036497b6c9-7327-4f63-9167-bf501c69bf9412012-07-24
54738-903-02EA - Each54738-90345ecc3cd-eabb-4c83-babf-a8891c71eb2012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SulindacACTIVE INGREDIENT184SNS8VUHSULINDAC TABLET [RICHMOND PHARMACEUTICALS]2
SulindacACTIVE MOIETY184SNS8VUHSULINDAC TABLET [RICHMOND PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54738-903SULINDAC TABLET [RICHMOND PHARMACEUTICALS]2Legacy NDC, 2 package rows20110603_89b01ca5-cfa5-4f5d-be6b-927d58cce0f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198238sulindac 150 MG Oral TabletPSN89b01ca5-cfa5-4f5d-be6b-927d58cce0f22
198239sulindac 200 MG Oral TabletPSN89b01ca5-cfa5-4f5d-be6b-927d58cce0f22
198238sulindac 150 MG Oral TabletSCD89b01ca5-cfa5-4f5d-be6b-927d58cce0f22
198239sulindac 200 MG Oral TabletSCD89b01ca5-cfa5-4f5d-be6b-927d58cce0f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54738-903-0154738090301100 in 1 BOTTLE, PLASTICHistorical
54738-903-0254738090302500 in 1 BOTTLE, PLASTICHistorical