ifosfamide

Generic: ifosfamide

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ifosfamide
Generic Name ifosfamide
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ifosfamide 1 g/1

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-142
Product ID 63323-142_14698d9d-9986-4f26-9bba-adb261002dc7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076078
Listing Expiration 2026-12-31
Marketing Start 2003-01-28

Pharmacologic Class

Established (EPC)
alkylating drug [epc]
Mechanism of Action
alkylating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323142
Hyphenated Format 63323-142

Supplemental Identifiers

RxCUI
1791593
UNII
UM20QQM95Y
NUI
N0000000236 N0000175558

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 ifosfamide (source: ndc)
Generic Name ifosfamide (source: ndc)
Application Number ANDA076078 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BOX (63323-142-12) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

63323-142-12 1 VIAL, SINGLE-DOSE in 1 BOX (63323-142-12) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Ingredients (1)

ifosfamide (1 g/1)

Linked Drug Pages (2)

Ifosfamide ndc-match (0.9) Ifosfamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "14698d9d-9986-4f26-9bba-adb261002dc7", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["UM20QQM95Y"], "rxcui": ["1791593"], "spl_set_id": ["fb7f49af-ffe9-4969-a69c-8ed14dd0616b"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BOX (63323-142-12)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "63323-142-12", "marketing_start_date": "20030128"}], "brand_name": "Ifosfamide", "product_id": "63323-142_14698d9d-9986-4f26-9bba-adb261002dc7", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "63323-142", "generic_name": "IFOSFAMIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ifosfamide", "active_ingredients": [{"name": "IFOSFAMIDE", "strength": "1 g/1"}], "application_number": "ANDA076078", "marketing_category": "ANDA", "marketing_start_date": "20030128", "listing_expiration_date": "20261231"}