Mycophenolic Acid (Page 10 of 10)

PRINCIPAL DISPLAY PANEL-180 mg

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

PRINCIPAL DISPLAY PANEL-360 mg

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

MYCOPHENOLIC ACID mycophenolic 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 (Mycophenolic Acid) Mycophenolic Acid 180 mg

Inactive Ingredients Ingredient Name Strength Silicon Dioxide Magnesium Stearate Anhydrous Lactose Crospovidone (35 .Mu.M) Povidone K30 Starch, Corn Hypromellose Phthalate (24% Phthalate, 55 Cst) Titanium Dioxide Fd&C Blue No. 2–Aluminum Lake Ferric Oxide Yellow

Product Characteristics Color green (Lime green) Score no score Shape ROUND Size 10mm Flavor Imprint Code B180 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70377-039-11 120 TABLET, DELAYED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214630 05/30/2022

MYCOPHENOLIC ACID mycophenolic 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 (Mycophenolic Acid) Mycophenolic Acid 360 mg

Inactive Ingredients Ingredient Name Strength Silicon Dioxide Magnesium Stearate Anhydrous Lactose Crospovidone (35 .Mu.M) Povidone K30 Starch, Corn Hypromellose Phthalate (24% Phthalate, 55 Cst) Titanium Dioxide Ferric Oxide Yellow Ferric Oxide Red

Product Characteristics Color RED (Orange Red) Score no score Shape OVAL Size 17mm Flavor Imprint Code B360 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70377-040-11 120 TABLET, DELAYED RELEASE in 1 BOTTLE None

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	Operations
Biocon Pharma Limited		871412155	analysis (70377-039), analysis (70377-040), manufacture (70377-039), manufacture (70377-040), pack (70377-039), pack (70377-040)

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

Revised: 06/2022 Biocon Pharma Inc.