NDC Code(s) : 69499-403-60
Packager : Solubiomix, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Coxantooxaprozin CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69499-403
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXAPROZIN(UNII: MHJ80W9LRB)
(OXAPROZIN - UNII:MHJ80W9LRB) 		OXAPROZIN300 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
STEARIC ACID(UNII: 4ELV7Z65AP)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code 403
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69499-403-6060 in 1 BOTTLE Type 0: Not a Combination Product24/10/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA217927 10/24/2023

LABELER - Solubiomix, LLC(079640556)

Establishment
Name Address ID/FEI Business Operations
Mikart, LLC 030034847 manufacture(69499-403)

PRINCIPAL DISPLAY PANEL

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 69499-403-60

Solubiomix

COXANTO
oxaprozin capsules

300 mg

60 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 300 mg Capsule Bottle Label