Ganciclovir
These highlights do not include all the information needed to use GANCICLOVIR INJECTION safely and effectively. See full prescribing information for GANCICLOVIR INJECTION. GANCICLOVIR injection, for intravenous use Initial U.S. Approval: 1989
Approved
Approval ID
3059c2da-d4a7-4aea-828c-20e671cb875c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2022
Manufacturers
FDA
Pharmascience Inc.
DUNS: 202657094
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ganciclovir sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51817-171
Application NumberANDA207645
Product Classification
M
Marketing Category
C73584
G
Generic Name
ganciclovir sodium
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 21, 2022
FDA Product Classification
INGREDIENTS (4)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GANCICLOVIR SODIUMActive
Quantity: 500 mg in 10 mL
Code: 02L083W284
Classification: ACTIM