NDC 0409-0801

Nipent

Pentostatin

Nipent is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Pentostatin.

• Product ID: 0409-0801_8fa82560-cea4-4272-9ae0-c97ac1635c8b
• NDC: 0409-0801
• Product Type: Human Prescription Drug
• Proprietary Name: Nipent
• Generic Name: Pentostatin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2007-08-15
• Marketing Category: NDA / NDA
• Application Number: NDA020122
• Labeler Name: Hospira, Inc.
• Substance Name: PENTOSTATIN
• Active Ingredient Strength: 2 mg/mL
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0409-0801-01

1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0801-01) > 5 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2007-08-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0409-0801-09 [00409080109]

Nipent INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020122
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-08-15
• Marketing End Date: 2016-10-01

NDC 0409-0801-01 [00409080101]

Nipent INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020122
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-08-15

Drug Details

Active Ingredients

Ingredient	Strength
PENTOSTATIN	2 mg/mL

OpenFDA Data

• SPL SET ID: 674e0e6d-46ed-4868-9196-04019d667716
• Manufacturer:
  • Hospira, Inc.
• UNII:
  • 395575MZO7
• RxNorm Concept Unique ID - RxCUI:
  • 240573
  • 105607

Pharmacological Class

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

NDC Crossover Matching brand name "Nipent" or generic name "Pentostatin"

NDC	Brand Name	Generic Name
0409-0801	Nipent	PENTOSTATIN
67457-288	Pentostatin	Pentostatin