busulfan

Generic: busulfan

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

Drug Facts

Product Profile

Brand Name busulfan
Generic Name busulfan
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

busulfan 6 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-1112
Product ID 0409-1112_1e2080b5-8c77-4eb1-95bf-4cbd86c27995
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205672
Listing Expiration 2026-12-31
Marketing Start 2019-02-28

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 04091112
Hyphenated Format 0409-1112

Supplemental Identifiers

RxCUI
253113
UNII
G1LN9045DK
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 busulfan (source: ndc)
Generic Name busulfan (source: ndc)
Application Number ANDA205672 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/mL
source: ndc
Packaging
  • 8 CARTON in 1 CARTON (0409-1112-01) / 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1112-10) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0409-1112-01 8 CARTON in 1 CARTON (0409-1112-01) / 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1112-10) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

busulfan (6 mg/mL)

Linked Drug Pages (1)

BUSULFAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1e2080b5-8c77-4eb1-95bf-4cbd86c27995", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["G1LN9045DK"], "rxcui": ["253113"], "spl_set_id": ["b9c7f0dc-988d-466e-8031-400ec4f60f21"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 CARTON in 1 CARTON (0409-1112-01)  / 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1112-10)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0409-1112-01", "marketing_start_date": "20190228"}], "brand_name": "BUSULFAN", "product_id": "0409-1112_1e2080b5-8c77-4eb1-95bf-4cbd86c27995", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "0409-1112", "generic_name": "BUSULFAN", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUSULFAN", "active_ingredients": [{"name": "BUSULFAN", "strength": "6 mg/mL"}], "application_number": "ANDA205672", "marketing_category": "ANDA", "marketing_start_date": "20190228", "listing_expiration_date": "20261231"}