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

Package Label 180 mg
(click image for full-size original)

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

Package Label 360 mg
(click image for full-size original)
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.

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