BUSULFEX

Product NDC

59148-047

11-digit product format

591480047

Labeler code

59148

Product ID

59148-047_d7b694d9-44f8-4c35-99ed-c8cf320e7ac5

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

busulfan

Dosage form

INJECTION

Route

INTRAVENOUS

Labeler

Otsuka America Pharmaceutical, Inc.

Application

NDA020954

Marketing category

NDA

Marketing start

2015-02-13

Marketing end

2021-01-31

Substance

BUSULFAN

Active strength

6 mg/mL

Pharmacologic classes

Alkylating Activity [MoA],Alkylating Drug [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record