NDC Code(s) : 70377-038-11
Packager : Biocon Phama Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

POSACONAZOLEPosaconazole TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-038
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Posaconazole(UNII: 6TK1G07BHZ)
(POSACONAZOLE - UNII:6TK1G07BHZ) 		Posaconazole100 mg
Inactive Ingredients
Ingredient Name Strength
Hypromellose Acetate Succinate 06081224 (3 Mm2/S)(UNII: 6N003M473W)
Microcrystalline Cellulose(UNII: OP1R32D61U)
Hydroxypropyl Cellulose (90000 Wamw)(UNII: UKE75GEA7F)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Croscarmellose Sodium(UNII: M28OL1HH48)
Magnesium Stearate(UNII: 70097M6I30)
Polyvinyl Alcohol, Unspecified(UNII: 532B59J990)
Polyethylene Glycol 3350(UNII: G2M7P15E5P)
Titanium Dioxide(UNII: 15FIX9V2JP)
Talc(UNII: 7SEV7J4R1U)
Ferric Oxide Yellow(UNII: EX438O2MRT)
Ferrosoferric Oxide(UNII: XM0M87F357)
Product Characteristics
Color YELLOW Score no score
Shape OVAL (oblong) Size 17 mm
Flavor Imprint Code B100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70377-038-1160 in 1 BOTTLE Type 0: Not a Combination Product03/08/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214476 03/08/2022

LABELER - Biocon Phama Inc.(080000063)

REGISTRANT - Biocon Pharma Limited(871412155)

Establishment
Name Address ID/FEI Business Operations
Biocon Pharma Limited 871412155 analysis(70377-038), manufacture(70377-038), pack(70377-038)

Establishment
Name Address ID/FEI Business Operations
Biocon Limited 915076162 api manufacture(70377-038)

PRINCIPAL DISPLAY PANEL

NDC 70377-038-11

Posaconazole Delayed-Release Tablets

100 mg

Attention: Noxafil® Oral Suspension and Posaconazole Delayed-
Release Tablets are NOT interchangeable due to
differences in the dosing of each formulation.

Rx only     60 Tablets

60-tab-label