NDC 23155-216

CIDOFOVIR DIHYDRATE

Cidofovir Dihydrate

CIDOFOVIR DIHYDRATE is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Heritage Pharmaceuticals Inc.. The primary component is Cidofovir.

• Product ID: 23155-216_17a6bf2d-eff0-468a-a27d-af1df2ee698c
• NDC: 23155-216
• Product Type: Human Prescription Drug
• Proprietary Name: CIDOFOVIR DIHYDRATE
• Generic Name: Cidofovir Dihydrate
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2012-08-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202501
• Labeler Name: Heritage Pharmaceuticals Inc.
• Substance Name: CIDOFOVIR
• Active Ingredient Strength: 375 mg/5mL
• Pharm Classes: Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 23155-216-31

5 mL in 1 VIAL, GLASS (23155-216-31)

• Marketing Start Date: 2012-08-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 23155-216-31 [23155021631]

CIDOFOVIR DIHYDRATE INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA202501
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-08-06

Drug Details

Active Ingredients

Ingredient	Strength
CIDOFOVIR	375 mg/5mL

OpenFDA Data

• SPL SET ID: 44966a7e-d777-40fb-956f-d0f31f737848
• Manufacturer:
  • Heritage Pharmaceuticals Inc.
• UNII:
  • JIL713Q00N
• RxNorm Concept Unique ID - RxCUI:
  • 199388
• UPC Code:
  • 0323155216318

Pharmacological Class

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