NDC Code(s) : 70377-039-11, 70377-040-11
Packager : Biocon Pharma Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Mycophenolic AcidMycophenolic Acid TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-039
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mycophenolate Sodium(UNII: WX877SQI1G)
(Mycophenolic Acid - UNII:HU9DX48N0T) 		Mycophenolic Acid180 mg
Inactive Ingredients
Ingredient Name Strength
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Magnesium Stearate(UNII: 70097M6I30)
Anhydrous Lactose(UNII: 3SY5LH9PMK)
Crospovidone (35 .Mu.M)(UNII: 40UAA97IT9)
Povidone K30(UNII: U725QWY32X)
Starch, Corn(UNII: O8232NY3SJ)
Hypromellose Phthalate (24% Phthalate, 55 Cst)(UNII: 87Y6436BKR)
Titanium Dioxide(UNII: 15FIX9V2JP)
Fd&C Blue No. 2--Aluminum Lake(UNII: 4AQJ3LG584)
Ferric Oxide Yellow(UNII: EX438O2MRT)
Product Characteristics
Color green (Lime green) Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code B180
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70377-039-11120 in 1 BOTTLE Type 0: Not a Combination Product30/05/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214630 05/30/2022
Mycophenolic AcidMycophenolic Acid TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70377-040
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Mycophenolate Sodium(UNII: WX877SQI1G)
(Mycophenolic Acid - UNII:HU9DX48N0T) 		Mycophenolic Acid360 mg
Inactive Ingredients
Ingredient Name Strength
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Magnesium Stearate(UNII: 70097M6I30)
Anhydrous Lactose(UNII: 3SY5LH9PMK)
Crospovidone (35 .Mu.M)(UNII: 40UAA97IT9)
Povidone K30(UNII: U725QWY32X)
Starch, Corn(UNII: O8232NY3SJ)
Hypromellose Phthalate (24% Phthalate, 55 Cst)(UNII: 87Y6436BKR)
Titanium Dioxide(UNII: 15FIX9V2JP)
Ferric Oxide Yellow(UNII: EX438O2MRT)
Ferric Oxide Red(UNII: 1K09F3G675)
Product Characteristics
Color RED (Orange Red) Score no score
Shape OVAL Size 17 mm
Flavor Imprint Code B360
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70377-040-11120 in 1 BOTTLE Type 0: Not a Combination Product30/05/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214630 05/30/2022

LABELER - Biocon Pharma Inc.(080000063)

REGISTRANT - Biocon Pharma Limited(871412155)

Establishment
Name Address ID/FEI Business Operations
Biocon Pharma Limited 871412155 analysis(70377-039, 70377-040), manufacture(70377-039, 70377-040), pack(70377-039, 70377-040)

Establishment
Name Address ID/FEI Business Operations
Biocon Limited 650173537 api manufacture(70377-039, 70377-040)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 70377-039-11

Mycophenolic Acid
Delayed-Release Tablets, USP

180 mg*

*as Mycophenolate sodium

Rx Only

PHARMACIST:Dispense the accompanying
Medication Guide to each patient.

120 Tablets

Package Label 180 mg

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 70377-040-11

Mycophenolic Acid
Delayed-Release Tablets, USP

360 mg*

*as Mycophenolate sodium

Rx Only

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

120 Tablets

Package Label 360 mg