Mycophenolic Acid (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 180 mg

Rx Only

NDC 68254-5001-1

Mycophenolic Acid*

Delayed-Release Tablets, USP

* as mycophenolate sodium

180 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient.

120 Tablets

image- 180mg-120s
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 360 mg

Rx Only

NDC 68254-5002-1

Mycophenolic Acid*

Delayed-Release Tablets, USP

* as mycophenolate sodium

360 mg

Pharmacist: Dispense the accompanying Medication Guide to each patient.

120 Tablets

image-360mg-120s
(click image for full-size original)
MYCOPHENOLIC ACID mycophenolic acid tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68254-5001
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
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
POVIDONE K30
SILICON DIOXIDE
TALC
MAGNESIUM STEARATE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
TRIETHYL CITRATE
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
Product Characteristics
Color GREEN (Lime green) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code C1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68254-5001-1 120 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:68254-5001-2 1000 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211173 12/13/2019
MYCOPHENOLIC ACID mycophenolic acid tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68254-5002
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
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
POVIDONE K30
SILICON DIOXIDE
TALC
MAGNESIUM STEARATE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
TRIETHYL CITRATE
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
Product Characteristics
Color PINK Score no score
Shape OVAL Size 17mm
Flavor Imprint Code C2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68254-5002-1 120 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:68254-5002-2 500 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211173 12/13/2019
Labeler — CONCORD BIOTECH LIMITED (916708337)
Registrant — CONCORD BIOTECH LIMITED (863283179)
Establishment
Name Address ID/FEI Operations
CONCORD BIOTECH LIMITED 650996940 ANALYSIS (68254-5001), ANALYSIS (68254-5002), LABEL (68254-5001), LABEL (68254-5002), PACK (68254-5001), PACK (68254-5002), MANUFACTURE (68254-5001), MANUFACTURE (68254-5002)

Revised: 06/2020 CONCORD BIOTECH LIMITED

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