Sulindac

Product NDC
55289-930
11-digit product format
552890930
Labeler code
55289
Product ID
55289-930_30ca698c-7fb2-9fa7-e063-6294a90abd86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulindac
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA071795
Marketing category
ANDA
Marketing start
1990-04-03
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55289-930-10Sulindac10 in 1 BOTTLE, PLASTICTABLET1014
55289-930-20Sulindac20 in 1 BOTTLE, PLASTICTABLET2014
55289-930-30Sulindac30 in 1 BOTTLE, PLASTICTABLET3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-930-10EA - Each55289-930a0ba5c37-5f19-4a22-adaf-5e18bbcb204c12012-07-24
55289-930-20EA - Each55289-9302171da87-b80f-496b-8781-2d30d97cc2fd12012-07-24
55289-930-30EA - Each55289-93051a0bb55-4781-4206-809d-1dab37763e5f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULINDACACTIVE INGREDIENT184SNS8VUHSULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.]1
SULINDACACTIVE MOIETY184SNS8VUHSULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-930SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 3 package rows20250322_68d4eeed-2501-494b-b979-502720de86c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198239sulindac 200 MG Oral TabletPSN68d4eeed-2501-494b-b979-502720de86c014
198239sulindac 200 MG Oral TabletSCD68d4eeed-2501-494b-b979-502720de86c014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-930-105528909301010 TABLET in 1 BOTTLE, PLASTIC (55289-930-10) 10 tablet2010-07-120000-00-00NoNoCurrent
55289-930-205528909302020 TABLET in 1 BOTTLE, PLASTIC (55289-930-20) 20 tablet2010-07-120000-00-00NoNoCurrent
55289-930-305528909303030 TABLET in 1 BOTTLE, PLASTIC (55289-930-30) 30 tablet2010-07-120000-00-00NoNoCurrent