Oxaprozin

Product NDC
57664-391
11-digit product format
576640391
Labeler code
57664
Product ID
57664-391_42a465c9-3cca-49aa-95bf-2658b3437218
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaprozin
Dosage form
TABLET
Route
ORAL
Labeler
Caraco Pharmaceutical Laboratories, Ltd.
Application
ANDA075844
Marketing category
ANDA
Marketing start
2002-01-03
Marketing end
0000-00-00
Substance
OXAPROZIN
Active strength
600 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-391-08EA - Each57664-3913f0a4a7e-1e98-4287-bc19-80fed57e1f3f12013-02-13
57664-391-13EA - Each57664-39136434924-3cbc-4330-af86-799751fd43e712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXAPROZINACTIVE INGREDIENTMHJ80W9LRBOXAPROZIN TABLET [DIRECT RX]1
OXAPROZINACTIVE INGREDIENTMHJ80W9LRBOXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
OXAPROZINACTIVE MOIETYMHJ80W9LRBOXAPROZIN TABLET [DIRECT RX]1
OXAPROZINACTIVE MOIETYMHJ80W9LRBOXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXAPROZIN TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXAPROZIN TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JOXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
METHYLCELLULOSE (400 MPA.S)INACTIVE INGREDIENTO0GN6F9B2YOXAPROZIN TABLET [DIRECT RX]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AOXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXAPROZIN TABLET [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOXAPROZIN TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXAPROZIN TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXAPROZIN TABLET [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXAPROZIN TABLET [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXAPROZIN TABLET [DIRECT RX]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312132oxaprozin 600 MG Oral TabletPSN53d958ba-7a60-461b-8622-b73831a007253
312132oxaprozin 600 MG Oral TabletSCD53d958ba-7a60-461b-8622-b73831a007253
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSY53d958ba-7a60-461b-8622-b73831a007253
312132oxaprozin 600 MG Oral TabletPSN18c897d3-47c2-461a-a0e7-0926453d45e31
312132oxaprozin 600 MG Oral TabletSCD18c897d3-47c2-461a-a0e7-0926453d45e31
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSY18c897d3-47c2-461a-a0e7-0926453d45e31