FDA.reportPublic FDA data

Oxaprozin

Product NDC
71335-0393
11-digit product format
713350393
Labeler code
71335
Product ID
71335-0393_115ad76f-3895-41b7-bc5a-a7a0975aca9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaprozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075855
Marketing category
ANDA
Marketing start
2001-01-31
Substance
OXAPROZIN
Active strength
600 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
Oxaprozin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXAPROZIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMHJ80W9LRB
Rxcui312132

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95b4bbb5-24e2-44a4-b351-d64e35d6e76aProduct name120250722
486cfca4-efa2-1446-eef2-3c74b667bb18Product name220170713

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0393-1Oxaprozin30 in 1 BOTTLETABLET, FILM COATED304
71335-0393-2Oxaprozin20 in 1 BOTTLETABLET, FILM COATED204
71335-0393-3Oxaprozin14 in 1 BOTTLETABLET, FILM COATED144
71335-0393-4Oxaprozin60 in 1 BOTTLETABLET, FILM COATED604
71335-0393-5Oxaprozin90 in 1 BOTTLETABLET, FILM COATED904
71335-0393-6Oxaprozin6 in 1 BOTTLETABLET, FILM COATED64
71335-0393-7Oxaprozin120 in 1 BOTTLETABLET, FILM COATED1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0393OXAPROZIN TABLET, FILM COATED [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 7 package rows20241004_dcb85e40-3427-4e56-910d-c1b07bb5c0fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312132oxaprozin 600 MG Oral TabletPSNdcb85e40-3427-4e56-910d-c1b07bb5c0fa4
312132oxaprozin 600 MG Oral TabletSCDdcb85e40-3427-4e56-910d-c1b07bb5c0fa4
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSYdcb85e40-3427-4e56-910d-c1b07bb5c0fa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-0393-17133503930130 TABLET, FILM COATED in 1 BOTTLE (71335-0393-1) 2007-09-12NoNoHistorical
71335-0393-27133503930220 TABLET, FILM COATED in 1 BOTTLE (71335-0393-2) 2007-09-12NoNoHistorical
71335-0393-37133503930314 TABLET, FILM COATED in 1 BOTTLE (71335-0393-3) 2007-09-12NoNoHistorical
71335-0393-47133503930460 TABLET, FILM COATED in 1 BOTTLE (71335-0393-4) 2007-09-12NoNoHistorical
71335-0393-57133503930590 TABLET, FILM COATED in 1 BOTTLE (71335-0393-5) 2007-09-12NoNoHistorical
71335-0393-6713350393066 TABLET, FILM COATED in 1 BOTTLE (71335-0393-6) 2007-09-12NoNoHistorical
71335-0393-771335039307120 TABLET, FILM COATED in 1 BOTTLE (71335-0393-7) 2007-09-12NoNoHistorical