busulfan

Generic: busulfan

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name busulfan
Generic Name busulfan
Labeler mylan institutional llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

busulfan 6 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-893
Product ID 67457-893_2ddd71e8-c2bd-4ee9-bef3-14891809fa28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208536
Marketing Start 2017-11-21
Marketing End 2026-05-31

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 67457893
Hyphenated Format 67457-893

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 ANDA208536 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/mL
source: ndc
Packaging
  • 8 VIAL, SINGLE-DOSE in 1 CARTON (67457-893-08) / 10 mL in 1 VIAL, SINGLE-DOSE (67457-893-00)
source: ndc

Packages (1)

67457-893-08 8 VIAL, SINGLE-DOSE in 1 CARTON (67457-893-08) / 10 mL in 1 VIAL, SINGLE-DOSE (67457-893-00)

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": "2ddd71e8-c2bd-4ee9-bef3-14891809fa28", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["G1LN9045DK"], "rxcui": ["253113"], "spl_set_id": ["9955aced-ac32-43e6-b39a-c6c023a50dc3"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 VIAL, SINGLE-DOSE in 1 CARTON (67457-893-08)  / 10 mL in 1 VIAL, SINGLE-DOSE (67457-893-00)", "package_ndc": "67457-893-08", "marketing_end_date": "20260531", "marketing_start_date": "20171121"}], "brand_name": "Busulfan", "product_id": "67457-893_2ddd71e8-c2bd-4ee9-bef3-14891809fa28", "dosage_form": "INJECTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "67457-893", "generic_name": "Busulfan", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Busulfan", "active_ingredients": [{"name": "BUSULFAN", "strength": "6 mg/mL"}], "application_number": "ANDA208536", "marketing_category": "ANDA", "marketing_end_date": "20260531", "marketing_start_date": "20171121"}