NDC 61269-450

Cytovene IV

Ganciclovir Sodium

Cytovene IV is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by H2-pharma, Llc. The primary component is Ganciclovir Sodium.

• Product ID: 61269-450_21f3f765-c9da-4d2a-a0b2-f3af9a25ffc4
• NDC: 61269-450
• Product Type: Human Prescription Drug
• Proprietary Name: Cytovene IV
• Generic Name: Ganciclovir Sodium
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1989-06-23
• Marketing Category: NDA / NDA
• Application Number: NDA019661
• Labeler Name: H2-Pharma, LLC
• Substance Name: GANCICLOVIR SODIUM
• Active Ingredient Strength: 500 mg/10mL
• Pharm Classes: Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 61269-450-50

5 VIAL in 1 CARTON (61269-450-50) > 10 mL in 1 VIAL

• Marketing Start Date: 1989-06-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61269-450-20 [61269045020]

Cytovene IV INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA019661
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1989-06-23

Drug Details

Active Ingredients

Ingredient	Strength
GANCICLOVIR SODIUM	500 mg/10mL

Pharmacological Class

• Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
• DNA Polymerase Inhibitors [MoA]
• Nucleoside Analog [EXT]
• Nucleoside Analog Antiviral [EPC]
• Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
• DNA Polymerase Inhibitors [MoA]
• Nucleoside Analog [EXT]
• Nucleoside Analog Antiviral [EPC]

NDC Crossover Matching brand name "Cytovene IV" or generic name "Ganciclovir Sodium"

NDC	Brand Name	Generic Name
0004-6940	Cytovene	ganciclovir sodium
61269-450	Cytovene	ganciclovir sodium
0143-9299	Ganciclovir	Ganciclovir sodium
14335-030	Ganciclovir	ganciclovir sodium
25021-185	ganciclovir	ganciclovir sodium
51817-171	Ganciclovir	ganciclovir sodium
63323-315	Ganciclovir	GANCICLOVIR SODIUM
70436-089	Ganciclovir	ganciclovir sodium
76233-072	Ganciclovir	Ganciclovir Sodium