busulfex

Generic: busulfan

Labeler: otsuka america pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name busulfex
Generic Name busulfan
Labeler otsuka america pharmaceutical, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

busulfan 6 mg/mL

Manufacturer
Otsuka America Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 59148-070
Product ID 59148-070_b281d2c1-122c-4a27-8a27-e222359c0fb9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020954
Listing Expiration 2026-12-31
Marketing Start 1999-02-04

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 59148070
Hyphenated Format 59148-070

Supplemental Identifiers

RxCUI
253113 284425
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 busulfex (source: ndc)
Generic Name busulfan (source: ndc)
Application Number NDA020954 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/mL
source: ndc
Packaging
  • 8 CARTON in 1 CARTON (59148-070-91) / 1 VIAL in 1 CARTON (59148-070-90) / 10 mL in 1 VIAL
source: ndc

Packages (1)

59148-070-91 8 CARTON in 1 CARTON (59148-070-91) / 1 VIAL in 1 CARTON (59148-070-90) / 10 mL in 1 VIAL

Ingredients (1)

busulfan (6 mg/mL)

Linked Drug Pages (1)

BUSULFEX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b281d2c1-122c-4a27-8a27-e222359c0fb9", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["G1LN9045DK"], "rxcui": ["253113", "284425"], "spl_set_id": ["5cb9d285-1803-4a99-946a-d0b239b32df6"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Otsuka America Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 CARTON in 1 CARTON (59148-070-91)  / 1 VIAL in 1 CARTON (59148-070-90)  / 10 mL in 1 VIAL", "package_ndc": "59148-070-91", "marketing_start_date": "19990204"}], "brand_name": "BUSULFEX", "product_id": "59148-070_b281d2c1-122c-4a27-8a27-e222359c0fb9", "dosage_form": "INJECTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "59148-070", "generic_name": "busulfan", "labeler_name": "Otsuka America Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BUSULFEX", "active_ingredients": [{"name": "BUSULFAN", "strength": "6 mg/mL"}], "application_number": "NDA020954", "marketing_category": "NDA", "marketing_start_date": "19990204", "listing_expiration_date": "20261231"}