nipent

Generic: pentostatin

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nipent
Generic Name pentostatin
Labeler hospira, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

pentostatin 2 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-0801
Product ID 0409-0801_e2a13722-66e8-48df-bf6a-65eca64068e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020122
Listing Expiration 2026-12-31
Marketing Start 2007-08-15

Pharmacologic Class

Established (EPC)
nucleoside metabolic inhibitor [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04090801
Hyphenated Format 0409-0801

Supplemental Identifiers

RxCUI
105607 240573
UNII
395575MZO7
NUI
N0000000233 N0000175595

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nipent (source: ndc)
Generic Name pentostatin (source: ndc)
Application Number NDA020122 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0801-01) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

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

Ingredients (1)

pentostatin (2 mg/mL)

Linked Drug Pages (1)

Nipent ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e2a13722-66e8-48df-bf6a-65eca64068e6", "openfda": {"nui": ["N0000000233", "N0000175595"], "unii": ["395575MZO7"], "rxcui": ["105607", "240573"], "spl_set_id": ["674e0e6d-46ed-4868-9196-04019d667716"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0801-01)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0409-0801-01", "marketing_start_date": "20070815"}], "brand_name": "Nipent", "product_id": "0409-0801_e2a13722-66e8-48df-bf6a-65eca64068e6", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "0409-0801", "generic_name": "PENTOSTATIN", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nipent", "active_ingredients": [{"name": "PENTOSTATIN", "strength": "2 mg/mL"}], "application_number": "NDA020122", "marketing_category": "NDA", "marketing_start_date": "20070815", "listing_expiration_date": "20261231"}