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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69853-0102	69853-0102-1	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69853-0102-1	EA - Each	69853-0102	5bf80020-bb71-4c40-b037-eb010c6756ca	1	2019-02-13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ANDEXXA	ANDEXANET ALFA	AstraZeneca Pharmaceuticals LP	2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c	2025-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125586

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125586	Andexxa	Coagulation Factor Xa (Recombinant), Inactivated-zhzo	351(a)	Disc	2026-09-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BI009E452R	ANDEXANET ALFA	1262449-58-0	ANDEXANET ALFA

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69853-0102-1	69853010201	4 VIAL, SINGLE-USE in 1 CARTON (69853-0102-1) > 20 mL in 1 VIAL, SINGLE-USE	2019-01-08	2024-11-30	No	No	Current