FDA.reportPublic FDA data

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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69853-0101DDiscontinued by firm2026-07-31
excluded packagepackage69853-010169853-0101-1DDiscontinued 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
69853-0101-1EA - Each69853-010113f30f97-0030-4602-905e-ab268aa66b7612018-06-11

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