MYLERAN

Product NDC
76388-713
11-digit product format
763880713
Labeler code
76388
Product ID
76388-713_63b6c09f-7819-4593-b1f8-300b1d810161
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
busulfan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aspen Global Inc.
Application
NDA009386
Marketing category
NDA
Marketing start
1985-03-21
Marketing end
2023-06-30
Substance
BUSULFAN
Active strength
2 mg/1
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76388-713-25EA - Each76388-7130dda4876-ece1-430d-83a2-066466e8b37412012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76388-713-257638807132525 TABLET, FILM COATED in 1 BOTTLE (76388-713-25) 1985-03-210000-00-00NoNoCurrent