BUSULFAN

Product NDC
0517-0920
11-digit product format
005170920
Labeler code
0517
Product ID
0517-0920_76ea7ec6-067a-4cda-bd44-87c21af78290
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUSULFAN
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
American Regent, Inc.
Application
ANDA202259
Marketing category
ANDA
Marketing start
2017-04-01
Marketing end
0000-00-00
Substance
BUSULFAN
Active strength
6 mg/mL
Pharmacologic classes
Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-0920-01ML - Milliliter0517-0920a116e16d-bb0e-4ebc-ab7e-a6c0f0a90e9f12017-04-05
0517-0920-08ML - Milliliter0517-0920b0438fb9-72ee-408c-a224-56f9356d040212017-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0517-0920-08005170920088 VIAL in 1 PACKAGE (0517-0920-08) > 10 mL in 1 VIAL (0517-0920-01) 8 vial2017-04-010000-00-00NoNoCurrent