SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – MYCOPHENOLATE MOFETIL 500 MG CONTAINER LABEL

NDC 70771-1084-1

Mycophenolate Mofetil for Injection, USP

(500 mg per Vial)

FOR INTRAVENOUS INFUSION ONLY

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

SINGLE DOSE VIAL

Rx only

Zydus Pharmaceuticals

PRINCIPAL DISPLAY PANEL - MYCOPHENOLATE MOFETIL 500 MG CARTON LABEL

NDC 70771-1084-8

Mycophenolate Mofetil for Injection, USP

(500 mg per Vial)

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

FOR INTRAVENOUS INFUSION ONLY

SINGLE DOSE VIAL

4 Vials

Rx only

Zydus Pharmaceuticals

MYCOPHENOLATE MOFETIL
mycophenolate mofetil injection, powder, lyophilized, for solution

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MYCOPHENOLATE MOFETIL (UNII: 9242ECW6R0) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T)	MYCOPHENOLATE MOFETIL	500 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1084-8	4 in 1 CARTON	09/22/2017
1		20 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204473	09/22/2017

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1084) , MANUFACTURE(70771-1084)