Home NDC 0310-3200 ANDEXXA
Product NDC 0310-3200
11-digit product format 003103200
Labeler code 0310
Product ID 0310-3200_7c42c928-30f8-44ac-a040-d3087b2d6074
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name andexanet alfa
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler AstraZeneca Pharmaceuticals LP
Application BLA125586
Marketing category BLA
Marketing start 2022-07-12
Marketing end 2027-12-31
Substance ANDEXANET ALFA
Active strength 200 mg/20mL
NDC exclude flag No
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ANDEXXA Active Ingredients# Ingredient, Strength table Ingredient Strength ANDEXANET ALFA 200 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BI009E452R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2108128 Internal RxNorm lookup 2108130 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0310-3200-01 ANDEXXA 20 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 20 7 0310-3200-04 ANDEXXA 4 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 4 7 0310-3200-05 ANDEXXA 5 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0310-3200 ANDEXXA (ANDEXANET ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTRAZENECA PHARMACEUTICALS LP] 6 Current NDC, Legacy NDC, 3 package rows 20250529_2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c.zip
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 ndc (product): 0310-3200
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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0310-3200-01 00310320001 20 mL in 1 VIAL, SINGLE-USE 20 ml Historical 0310-3200-04 00310320004 4 VIAL, SINGLE-USE in 1 CARTON (0310-3200-04) / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01) 2022-07-12 2027-12-31 No No Current 0310-3200-05 00310320005 5 VIAL, SINGLE-USE in 1 CARTON (0310-3200-05) / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01) 2023-07-03 2027-11-30 No No Historical