Label: MYCOPHENOLATE MOFETIL injection, powder, lyophilized, for solution
- NDC Code(s): 70771-1084-8
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 3, 2023
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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
-
INGREDIENTS AND APPEARANCE
MYCOPHENOLATE MOFETIL
mycophenolate mofetil injection, powder, lyophilized, for solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1084 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MYCOPHENOLATE MOFETIL (UNII: 9242ECW6R0) (MYCOPHENOLIC ACID - UNII:HU9DX48N0T) MYCOPHENOLATE MOFETIL 500 mg in 20 mL Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 (UNII: 6OZP39ZG8H) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204473 09/22/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1084) , MANUFACTURE(70771-1084)