Oxaprozin

Product NDC
60760-382
11-digit product format
607600382
Labeler code
60760
Product ID
60760-382_5269e91f-7e95-9405-e063-6294a90a3217
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaprozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ST MARY'S MEDICAL PARK PHARMACY
Application
ANDA075855
Marketing category
ANDA
Marketing start
2022-08-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxaprozin
Listing expiration
2027-12-31

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
60760-382-14Oxaprozin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED144

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-382-14EA - Each60760-382e680847a-ec39-4ef1-93fc-25a314bb2a1c12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-382OXAPROZIN TABLET, FILM COATED [ST MARY'S MEDICAL PARK PHARMACY]1Current NDC, Legacy NDC, 1 package rows20220914_e881dca6-004e-1c3e-e053-2a95a90a02ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312132oxaprozin 600 MG Oral TabletPSNe881dca6-004e-1c3e-e053-2a95a90a02ab4
312132oxaprozin 600 MG Oral TabletSCDe881dca6-004e-1c3e-e053-2a95a90a02ab4
312132oxaprozin 600 MG (as oxaprozin potassium 678 MG) Oral TabletSYe881dca6-004e-1c3e-e053-2a95a90a02ab4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-382-146076003821414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-382-14) 2022-08-150000-00-00NoNoCurrent