ifosfamide

Generic: ifosfamide

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ifosfamide
Generic Name ifosfamide
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

ifosfamide 50 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9531
Product ID 0143-9531_dc31337c-ac3a-4d47-88d2-823e4181688a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076619
Listing Expiration 2026-12-31
Marketing Start 2017-06-10

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 01439531
Hyphenated Format 0143-9531

Supplemental Identifiers

RxCUI
1791597 1791599
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 ANDA076619 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX (0143-9531-01) / 20 mL in 1 VIAL
source: ndc

Packages (1)

0143-9531-01 1 VIAL in 1 BOX (0143-9531-01) / 20 mL in 1 VIAL

Ingredients (1)

ifosfamide (50 mg/mL)

Linked Drug Pages (1)

Ifosfamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "dc31337c-ac3a-4d47-88d2-823e4181688a", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["UM20QQM95Y"], "rxcui": ["1791597", "1791599"], "spl_set_id": ["c90ab05f-8fe5-437e-a1c0-8b11ef63291e"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX (0143-9531-01)  / 20 mL in 1 VIAL", "package_ndc": "0143-9531-01", "marketing_start_date": "20170610"}], "brand_name": "Ifosfamide", "product_id": "0143-9531_dc31337c-ac3a-4d47-88d2-823e4181688a", "dosage_form": "INJECTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "0143-9531", "generic_name": "Ifosfamide", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ifosfamide", "active_ingredients": [{"name": "IFOSFAMIDE", "strength": "50 mg/mL"}], "application_number": "ANDA076619", "marketing_category": "ANDA", "marketing_start_date": "20170610", "listing_expiration_date": "20261231"}