FDA.reportPublic FDA data

Sulindac

Product NDC
52959-195
11-digit product format
529590195
Labeler code
52959
Product ID
52959-195_91275e67-c112-480e-b4c9-1de9f51ac081
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulindac
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA071795
Marketing category
ANDA
Marketing start
1990-04-03
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
2018-12-31
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
52959-195-142020-01-31C16284748780-19d75b9cf-dab7-f424-e053-dadaa90a57ceSulindac Tablets USP Revised: June 2009 Rx only 190770
52959-195-152020-01-31C16284748780-19d75b9cf-dab7-f424-e053-dadaa90a57ceSulindac Tablets USP Revised: June 2009 Rx only 190770
52959-195-182020-01-31C16284748780-19d75b9cf-dab7-f424-e053-dadaa90a57ceSulindac Tablets USP Revised: June 2009 Rx only 190770
52959-195-202020-01-31C16284748780-19d75b9cf-dab7-f424-e053-dadaa90a57ceSulindac Tablets USP Revised: June 2009 Rx only 190770
52959-195-282020-01-31C16284748780-19d75b9cf-dab7-f424-e053-dadaa90a57ceSulindac Tablets USP Revised: June 2009 Rx only 190770
52959-195-302020-01-31C16284748780-19d75b9cf-dab7-f424-e053-dadaa90a57ceSulindac Tablets USP Revised: June 2009 Rx only 190770
52959-195-602020-01-31C16284748780-19d75b9cf-dab7-f424-e053-dadaa90a57ceSulindac Tablets USP Revised: June 2009 Rx only 190770

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-195-14Sulindac14 in 1 BOTTLE, PLASTICTABLET141
52959-195-15Sulindac15 in 1 BOTTLE, PLASTICTABLET151
52959-195-18Sulindac18 in 1 BOTTLE, PLASTICTABLET181
52959-195-20Sulindac20 in 1 BOTTLE, PLASTICTABLET201
52959-195-28Sulindac28 in 1 BOTTLE, PLASTICTABLET281
52959-195-30Sulindac30 in 1 BOTTLE, PLASTICTABLET301
52959-195-60Sulindac60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-195-14EA - Each52959-195c5d923c7-1e58-4669-89ee-b614435167f212012-07-24
52959-195-15EA - Each52959-1959b4c50ad-5c6d-41e6-8828-4f5cec74086612012-07-24
52959-195-18EA - Each52959-1955b26f83e-9b1b-45bb-9d73-561d2ce85f4f12015-10-02
52959-195-20EA - Each52959-195c1e89864-25a9-4258-b55f-37714699657612012-07-24
52959-195-28EA - Each52959-195ce4f1e1f-56eb-41d2-b8bc-7cbff69d12ae12012-07-24
52959-195-30EA - Each52959-1954810331c-7c07-46b5-8bc2-b58b2df2897d12012-07-24
52959-195-60EA - Each52959-1957009e183-6751-48c0-ae71-72c831d4cd7912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULINDACACTIVE INGREDIENT184SNS8VUHSULINDAC TABLET [H.J. HARKINS COMPANY, INC.]1
SULINDACACTIVE MOIETY184SNS8VUHSULINDAC TABLET [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USULINDAC TABLET [H.J. HARKINS COMPANY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULINDAC TABLET [H.J. HARKINS COMPANY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULINDAC TABLET [H.J. HARKINS COMPANY, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSULINDAC TABLET [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-195SULINDAC TABLET [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 7 package rows20111201_145a1b4a-16ef-4f29-b47e-f52c47514c9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198239sulindac 200 MG Oral TabletPSN145a1b4a-16ef-4f29-b47e-f52c47514c9a1
198239sulindac 200 MG Oral TabletSCD145a1b4a-16ef-4f29-b47e-f52c47514c9a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-195-145295901951414 in 1 BOTTLE, PLASTICHistorical
52959-195-155295901951515 in 1 BOTTLE, PLASTICHistorical
52959-195-185295901951818 in 1 BOTTLE, PLASTICHistorical
52959-195-205295901952020 in 1 BOTTLE, PLASTICHistorical
52959-195-285295901952828 in 1 BOTTLE, PLASTICHistorical
52959-195-305295901953030 in 1 BOTTLE, PLASTICHistorical
52959-195-605295901956060 in 1 BOTTLE, PLASTICHistorical