FDA.reportPublic FDA data

SULINDAC

Product NDC
72789-374
11-digit product format
727890374
Labeler code
72789
Product ID
72789-374_31f654da-06fe-9e86-e063-6294a90a3312
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulindac
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA072051
Marketing category
ANDA
Marketing start
2009-09-04
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
72789-374-01SULINDAC100 in 1 BOTTLE, PLASTICTABLET10022
72789-374-82SULINDAC500 in 1 BOTTLE, PLASTICTABLET50022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-374-01EA - Each72789-3744b532298-35fc-4b36-93e6-dc211178466e12024-02-14
72789-374-82EA - Each72789-3743199ea8b-7e58-4597-9d2f-1c6ea9d3648812024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-374SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.]22Current NDC, 2 package rows20250406_1fffe88d-50c8-45cf-ac7c-a62b665c89a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198239sulindac 200 MG Oral TabletPSN1fffe88d-50c8-45cf-ac7c-a62b665c89a822
198239sulindac 200 MG Oral TabletSCD1fffe88d-50c8-45cf-ac7c-a62b665c89a822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-374-0172789037401100 TABLET in 1 BOTTLE, PLASTIC (72789-374-01) 100 tablet2024-08-27NoNoHistorical
72789-374-8272789037482500 TABLET in 1 BOTTLE, PLASTIC (72789-374-82) 500 tablet2024-01-25NoNoHistorical