GANCICLOVIR- ganciclovir sodium injection, powder, lyophilized, for solution 
Mylan Laboratories Limited

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GANCICLOVIR FOR INJECTION

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 67457-387-99

Ganciclovir for Injection, USP

500 mg/vial

FOR INTRAVENOUS INFUSION ONLY

Lyophilized Powder

Sterile

CAUTION: Handle this product with great care because it is a potent cytotoxic agent and suspected carcinogen.

Mylan

Rx only

10 x 500 mg Vials

Carton 500 mg
GANCICLOVIR 
ganciclovir sodium injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:47351-077
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GANCICLOVIR SODIUM (UNII: 02L083W284) (GANCICLOVIR - UNII:P9G3CKZ4P5) GANCICLOVIR500 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47351-077-9910 in 1 CARTON12/31/2017
110 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractANDA20456012/31/2017
Labeler - Mylan Laboratories Limited (650548014)

Revised: 11/2017
Document Id: 19e62905-f675-44c7-9e8f-f5b39e6296eb
Set id: 19e62905-f675-44c7-9e8f-f5b39e6296eb
Version: 1
Effective Time: 20171121
 
Mylan Laboratories Limited