Ganciclovir

Product NDC
76233-072
11-digit product format
762330072
Labeler code
76233
Product ID
76233-072_1187c030-f17b-46ad-8be6-69f0bea3ff41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ganciclovir Sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Laboratorio Reig Jofre, S.A.
Application
ANDA207815
Marketing category
ANDA
Marketing start
2020-08-25
Marketing end
0000-00-00
Substance
GANCICLOVIR SODIUM
Active strength
500 mg/10mL
Pharmacologic classes
Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76233-072-947623300729425 VIAL in 1 CARTON (76233-072-94) > 10 mL in 1 VIAL (76233-072-10) 25 vial2020-08-250000-00-00NoNoCurrent