ANDEXXA

Product NDC
69853-0102
11-digit product format
698530102
Labeler code
69853
Product ID
69853-0102_6e8a9040-9ed4-4ef6-b782-1898fce3f76e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
andexanet alfa
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Alexion Pharmaceuticals, Inc.
Application
BLA125586
Marketing category
BLA
Marketing start
2019-01-08
Marketing end
2024-11-30
Substance
ANDEXANET ALFA
Active strength
200 mg/20mL
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
69853-0102-1EA - Each69853-01025bf80020-bb71-4c40-b037-eb010c6756ca12019-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69853-0102-1698530102014 VIAL, SINGLE-USE in 1 CARTON (69853-0102-1) > 20 mL in 1 VIAL, SINGLE-USE2019-01-080000-00-00NoNoCurrent