NDC 67457-210

Cidofovir

Cidofovir Anhydrous

Cidofovir is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Cidofovir.

• Product ID: 67457-210_28d8ed18-6d69-443a-a9ed-1dd5885f493f
• NDC: 67457-210
• Product Type: Human Prescription Drug
• Proprietary Name: Cidofovir
• Generic Name: Cidofovir Anhydrous
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2013-06-03
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201276
• Labeler Name: Mylan Institutional LLC
• Substance Name: CIDOFOVIR
• Active Ingredient Strength: 75 mg/mL
• Pharm Classes: Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 67457-210-05

1 VIAL, GLASS in 1 CARTON (67457-210-05) > 5 mL in 1 VIAL, GLASS

• Marketing Start Date: 2013-06-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-210-05 [67457021005]

Cidofovir INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA201276
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-06-03

Drug Details

Active Ingredients

Ingredient	Strength
CIDOFOVIR	75 mg/mL

OpenFDA Data

• SPL SET ID: 56541229-8c1a-4550-8951-2415ed08e7e9
• Manufacturer:
  • Mylan Institutional LLC
• UNII:
  • JIL713Q00N
• RxNorm Concept Unique ID - RxCUI:
  • 199388

Pharmacological Class

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

NDC Crossover Matching brand name "Cidofovir" or generic name "Cidofovir Anhydrous"

NDC	Brand Name	Generic Name
67457-210	Cidofovir	Cidofovir Anhydrous
61958-0101	Vistide	CIDOFOVIR