NDC 70436-089

Ganciclovir

Ganciclovir Sodium

Ganciclovir is a Intraventricular Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Slate Run Pharmaceuticals. The primary component is Ganciclovir Sodium.

• Product ID: 70436-089_80b8aaf3-69b7-7f80-e053-2991aa0ae899
• NDC: 70436-089
• Product Type: Human Prescription Drug
• Proprietary Name: Ganciclovir
• Generic Name: Ganciclovir Sodium
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENTRICULAR
• Marketing Start Date: 2019-02-11
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204204
• Labeler Name: Slate Run Pharmaceuticals
• Substance Name: GANCICLOVIR SODIUM
• Active Ingredient Strength: 50 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 70436-089-55

25 VIAL in 1 CARTON (70436-089-55) > 10 mL in 1 VIAL

• Marketing Start Date: 2019-02-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70436-089-55 [70436008955]

Ganciclovir INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA204204
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-02-11

Drug Details

Active Ingredients

Ingredient	Strength
GANCICLOVIR SODIUM	50 mg/mL

OpenFDA Data

• SPL SET ID: eb100366-2a64-4742-af11-6177a8a494c8
• Manufacturer:
  • Slate Run Pharmaceuticals
• UNII:
  • 02L083W284
• RxNorm Concept Unique ID - RxCUI:
  • 310442
• UPC Code:
  • 0370436089550

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 Sodium"

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
0004-6940	Cytovene	ganciclovir sodium
61269-450	Cytovene	ganciclovir sodium
24208-535	ZIRGAN	ganciclovir