Busulfan

Product NDC
70860-216
11-digit product format
708600216
Labeler code
70860
Product ID
70860-216_8189e34d-4b3d-4a39-a42f-870cfd05baaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
busulfan
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA205106
Marketing category
ANDA
Marketing start
2019-02-10
Marketing end
2021-07-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-216-10ML - Milliliter70860-216b6e12cdb-240b-4e3e-9391-88e8bdf927ee12019-04-11
70860-216-41ML - Milliliter70860-21649a3669f-ba7e-422c-908d-7d164ada498012019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70860-216-10708600216108 VIAL in 1 CARTON (70860-216-10) > 10 mL in 1 VIAL (70860-216-41) 8 vial2019-02-102021-07-31NoNoCurrent