GAMIFANT

Product NDC
72171-501
11-digit product format
721710501
Labeler code
72171
Product ID
72171-501_76c15230-d1ad-42ad-8d9a-db09afed5e73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
(emapalumab-lzsg)
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
NovImmune SA
Application
BLA761107
Marketing category
BLA
Marketing start
2018-11-20
Marketing end
2021-11-30
Substance
EMAPALUMAB
Active strength
10 mg/2mL
Pharmacologic classes
Interferon gamma Blocker [EPC],Interferon gamma Antagonists [MoA]
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
72171-501-01ML - Milliliter72171-50119fba6ba-6451-430a-8b68-7dd27630f70712019-01-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72171-501-01721710501011 VIAL, SINGLE-USE in 1 CARTON (72171-501-01) > 2 mL in 1 VIAL, SINGLE-USE2018-11-202021-11-30NoNoCurrent