FDA.reportPublic FDA data

OXAPROZIN

Product NDC
61919-673
11-digit product format
619190673
Labeler code
61919
Product ID
61919-673_86e2a6b6-005d-493b-e053-2a91aa0a5376
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXAPROZIN
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA075845
Marketing category
ANDA
Marketing start
2019-04-19
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
2020-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-673-602024-01-30C16284748780-11030e365-6553-111a-e063-dadaa90a10e2OXAPROZIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-673-60OXAPROZIN60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-673-60EA - Each61919-673b186ad31-972c-404f-8a3f-ae8ab9a3ba0012019-05-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-673OXAPROZIN TABLET [DIRECT RX]3Legacy NDC, 1 package rows20190420_53d958ba-7a60-461b-8622-b73831a00725.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-673-606191906736060 TABLET in 1 BOTTLE (61919-673-60) 60 tablet2019-04-190000-00-00NoNoCurrent