FDA.reportPublic FDA data

ANDEXXA

Product NDC
69853-0102
Requested package NDC
69853-0102-1
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69853-010269853-0102-1DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANDEXXAANDEXANET ALFAAstraZeneca Pharmaceuticals LP2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c2025-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125586

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125586AndexxaCoagulation Factor Xa (Recombinant), Inactivated-zhzo351(a)Disc2026-06-01

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-USE2019-01-082024-11-30NoNoCurrent