ANDEXXA

Product NDC

69853-0101

11-digit product format

698530101

Labeler code

69853

Product ID

69853-0101_66dcac76-655d-4aeb-9111-14adc2c9fd70

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

andexanet alfa

Dosage form

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Route

INTRAVENOUS

Labeler

Portola Pharmaceuticals

Application

BLA125586

Marketing category

BLA

Marketing start

2018-05-14

Marketing end

2020-10-31

Substance

ANDEXANET ALFA

Active strength

100 mg/10mL

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record