NDC 25021-237

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 Sagent Pharmaceuticals. The primary component is Fludarabine Phosphate.

• Product ID: 25021-237_18f5feab-3c38-40f5-a595-6a6c66762af2
• NDC: 25021-237
• 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: 2014-12-15
• Marketing End Date: 2020-06-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076349
• Labeler Name: Sagent Pharmaceuticals
• Substance Name: FLUDARABINE PHOSPHATE
• Active Ingredient Strength: 25 mg/mL
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N

Packaging

NDC 25021-237-06

1 VIAL in 1 CARTON (25021-237-06) > 2 mL in 1 VIAL

• Marketing Start Date: 2014-12-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 25021-237-06 [25021023706]

fludarabine phosphate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA076349
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-12-15
• Marketing End Date: 2019-06-30

Drug Details

Active Ingredients

Ingredient	Strength
FLUDARABINE PHOSPHATE	25 mg/mL

OpenFDA Data

• SPL SET ID: 763d6c6d-cfed-4813-8cc5-41e78d357845
• Manufacturer:
  • Sagent Pharmaceuticals
• UNII:
  • 1X9VK9O1SC
• RxNorm Concept Unique ID - RxCUI:
  • 1740864

Pharmacological Class

• 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