NDC 51754-2500

GANCICLOVIR

Ganciclovir

GANCICLOVIR is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Exela Pharma Sciences, Llc. The primary component is Ganciclovir.

• Product ID: 51754-2500_238a983f-81bb-4033-b6ca-5fee7d6d291c
• NDC: 51754-2500
• Product Type: Human Prescription Drug
• Proprietary Name: GANCICLOVIR
• Generic Name: Ganciclovir
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-02-28
• Marketing Category: NDA / NDA
• Application Number: NDA209347
• Labeler Name: EXELA PHARMA SCIENCES, LLC
• Substance Name: GANCICLOVIR
• Active Ingredient Strength: 2 mg/mL
• 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 51754-2500-1

250 mL in 1 BAG (51754-2500-1)

• Marketing Start Date: 2017-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51754-2500-3 [51754250003]

GANCICLOVIR INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA209347
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-02-28

NDC 51754-2500-1 [51754250001]

GANCICLOVIR INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA209347
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-02-28

Drug Details

Active Ingredients

Ingredient	Strength
GANCICLOVIR	2 mg/mL

OpenFDA Data

• SPL SET ID: 26361de8-39b5-4266-90f6-2b307940135d
• Manufacturer:
  • EXELA PHARMA SCIENCES, LLC
• UNII:
  • P9G3CKZ4P5
• RxNorm Concept Unique ID - RxCUI:
  • 1872065

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