NDC 42023-173

Ganciclovir

Ganciclovir

Ganciclovir is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Ganciclovir Sodium.

• Product ID: 42023-173_8972ed8b-66cf-4a71-878e-9564a0ab2d13
• NDC: 42023-173
• Product Type: Human Prescription Drug
• Proprietary Name: Ganciclovir
• Generic Name: Ganciclovir
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-12-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204950
• Labeler Name: Par Pharmaceutical, Inc.
• 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 42023-173-25

25 VIAL, SINGLE-DOSE in 1 CARTON (42023-173-25) > 10 mL in 1 VIAL, SINGLE-DOSE (42023-173-01)

• Marketing Start Date: 2016-12-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42023-173-01 [42023017301]

Ganciclovir INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA204950
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-12-06

NDC 42023-173-25 [42023017325]

Ganciclovir INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA204950
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-12-06

Drug Details

Active Ingredients

Ingredient	Strength
GANCICLOVIR SODIUM	500 mg/10mL

OpenFDA Data

• SPL SET ID: 87afd103-6e64-444f-971d-0e732e9ae995
• Manufacturer:
  • Par Pharmaceutical, Inc.
• UNII:
  • 02L083W284
• RxNorm Concept Unique ID - RxCUI:
  • 310442

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 "Ganciclovir" or generic name "Ganciclovir"

NDC	Brand Name	Generic Name
0143-9299	Ganciclovir	Ganciclovir sodium
14335-030	Ganciclovir	ganciclovir sodium
24201-500	Ganciclovir	Ganciclovir
25021-185	ganciclovir	ganciclovir sodium
42023-173	Ganciclovir	Ganciclovir
51754-2500	GANCICLOVIR	GANCICLOVIR
51817-171	Ganciclovir	ganciclovir sodium
63304-636	GANCICLOVIR	GANCICLOVIR
63304-637	GANCICLOVIR	GANCICLOVIR
63323-315	Ganciclovir	GANCICLOVIR SODIUM
70436-089	Ganciclovir	ganciclovir sodium
76233-072	Ganciclovir	Ganciclovir Sodium
24208-535	ZIRGAN	ganciclovir