Oxaprozin

Product NDC
72189-595
11-digit product format
721890595
Labeler code
72189
Product ID
72189-595_284ce161-0a4b-8999-e063-6394a90aa60a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaprozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA075855
Marketing category
ANDA
Marketing start
2024-12-02
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
72189-595-60Oxaprozin60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-595OXAPROZIN TABLET, FILM COATED [DIRECT_RX]1Current NDC, 1 package rows20241204_284ce161-0a4a-8999-e063-6394a90aa60a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312132oxaprozin 600 MG Oral TabletPSN284ce161-0a4a-8999-e063-6394a90aa60a1
312132oxaprozin 600 MG Oral TabletSCD284ce161-0a4a-8999-e063-6394a90aa60a1
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSY284ce161-0a4a-8999-e063-6394a90aa60a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-595-607218905956060 TABLET, FILM COATED in 1 BOTTLE (72189-595-60) 2024-12-02NoNoCurrent