NDC 45963-609

Fludarabine phosphate

Fludarabine Phosphate

Fludarabine phosphate is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Fludarabine Phosphate.

• Product ID: 45963-609_13fec225-ce1e-4855-936d-7166a066ba9a
• NDC: 45963-609
• Product Type: Human Prescription Drug
• Proprietary Name: Fludarabine phosphate
• Generic Name: Fludarabine Phosphate
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2015-01-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078610
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: FLUDARABINE PHOSPHATE
• Active Ingredient Strength: 50 mg/2mL
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 45963-609-55

1 VIAL, GLASS in 1 CARTON (45963-609-55) > 2 mL in 1 VIAL, GLASS

• Marketing Start Date: 2015-01-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45963-609-55 [45963060955]

Fludarabine phosphate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078610
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-01-05

Drug Details

Active Ingredients

Ingredient	Strength
FLUDARABINE PHOSPHATE	50 mg/2mL

OpenFDA Data

• SPL SET ID: 3adca34b-4f65-4e21-8058-3c01fc7fc9bb
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • 1X9VK9O1SC
• RxNorm Concept Unique ID - RxCUI:
  • 1740864
• UPC Code:
  • 0345963609557

Pharmacological Class

• Nucleic Acid Synthesis Inhibitors [MoA]
• Nucleoside Metabolic Inhibitor [EPC]
• Nucleic Acid Synthesis Inhibitors [MoA]
• Nucleoside Metabolic Inhibitor [EPC]

NDC Crossover Matching brand name "Fludarabine phosphate" or generic name "Fludarabine Phosphate"

NDC	Brand Name	Generic Name
16729-131	FLUDARABINE PHOSPHATE	FLUDARABINE
24201-237	fludarabine phosphate	fludarabine phosphate
25021-237	fludarabine phosphate	fludarabine phosphate
25021-242	Fludarabine Phosphate	Fludarabine Phosphate
45963-609	Fludarabine phosphate	Fludarabine phosphate
45963-621	Fludarabine phosphate	Fludarabine phosphate
59923-604	Fludarabine Phosphate	Fludarabine Phosphate
61703-344	Fludarabine Phosphate	FLUDARABINE PHOSPHATE
66758-046	Fludarabine Phosphate	Fludarabine Phosphate
63323-192	Fludarabine	FLUDARABINE PHOSPHATE