FDA.reportPublic FDA data

SULINDAC

Product NDC
72789-373
11-digit product format
727890373
Labeler code
72789
Product ID
72789-373_41d72ed1-2f68-852b-e063-6294a90a6401
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulindac
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA072050
Marketing category
ANDA
Marketing start
2009-09-04
Substance
SULINDAC
Active strength
150 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
SULINDAC150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii184SNS8VUH
Rxcui198238

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
72789-373-01SULINDAC100 in 1 BOTTLE, PLASTICTABLET10022
72789-373-82SULINDAC500 in 1 BOTTLE, PLASTICTABLET50022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-373-01EA - Each72789-37370e4d53e-af07-4bc5-8a3f-fad6084fb65312024-02-14
72789-373-82EA - Each72789-373678fcd79-337c-434c-a58e-a016b3f3d16b12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-373SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.]21Current NDC, 2 package rows20250406_eb7acb87-6565-4524-a91a-02064ea8bd1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198238sulindac 150 MG Oral TabletPSNeb7acb87-6565-4524-a91a-02064ea8bd1a22
198238sulindac 150 MG Oral TabletSCDeb7acb87-6565-4524-a91a-02064ea8bd1a22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-373-0172789037301100 TABLET in 1 BOTTLE, PLASTIC (72789-373-01) 100 tablet2024-01-19NoNoCurrent
72789-373-8272789037382500 TABLET in 1 BOTTLE, PLASTIC (72789-373-82) 500 tablet2024-01-25NoNoCurrent