EVOMELA

Product NDC
69605-001
11-digit product format
696050001
Labeler code
69605
Product ID
69605-001_d44fac6f-e1e1-399d-e053-2a95a90a81f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Melphalan
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
CENEXI - BLA
Application
NDA207155
Marketing category
NDA
Marketing start
2016-03-31
Marketing end
0000-00-00
Substance
MELPHALAN HYDROCHLORIDE
Active strength
50 mg/10mL
Pharmacologic classes
Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69605-001-01696050001011 VIAL in 1 CARTON (69605-001-01) > 20 mL in 1 VIAL1 vial2016-03-310000-00-00NoNoCurrent