Oxaprozin

Product NDC
70512-787
11-digit product format
705120787
Labeler code
70512
Product ID
70512-787_450f5941-7f11-42fe-e063-6394a90a4803
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxaprozin
Dosage form
CAPSULE
Route
ORAL
Labeler
SOLA Pharmaceuticals, LLC
Application
NDA217927
Marketing category
NDA
Marketing start
2025-12-03
Substance
OXAPROZIN
Active strength
300 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
OXAPROZIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMHJ80W9LRB
Rxcui2668162

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
70512-787-60Oxaprozin60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-787-60EA - Each70512-787901ba0d3-bab5-4be9-bf9e-d6eee5a3305b12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2668162oxaprozin 300 MG Oral CapsulePSN450f5941-7f10-42fe-e063-6394a90a48031
2668162oxaprozin 300 MG Oral CapsuleSCD450f5941-7f10-42fe-e063-6394a90a48031
2668162oxaprozin 300 MG Oral CapsuleSY450f5941-7f10-42fe-e063-6394a90a48031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70512-787-607051207876060 CAPSULE in 1 BOTTLE (70512-787-60) 60 capsule2025-12-03NoNoHistorical