Cytovene

Product NDC: 61269-450
11-digit product format: 612690450
Labeler code: 61269
Product ID: 61269-450_a5364479-826e-4791-92d3-a631355ae2f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ganciclovir sodium
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: H2-Pharma, LLC
Application: NDA019661
Marketing category: NDA
Marketing start: 1989-06-23
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: 2022-12-31
Current FDA listing: Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61269-450-20	EA - Each	61269-450	d15b8f19-4c5e-497c-9cce-dad28dc6f49b	1	2019-12-10

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
02L083W284	GANCICLOVIR SODIUM	107910-75-8	GANCICLOVIR SODIUM

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61269-450-50	61269045050	5 VIAL in 1 CARTON (61269-450-50) > 10 mL in 1 VIAL	5 vial	1989-06-23	0000-00-00	No	No	Current