FDA.reportPublic FDA data

NDC 0310-3200-01 - ANDEXXA

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0310-3200
Requested NDC
0310-3200-01
Package NDCs from labels
0310-3200-01, 0310-3200-04, 0310-3200-05
Manufacturer
AstraZeneca Pharmaceuticals LP | AstraZeneca PLC
Effective date
2025-05-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ANDEXXA - AstraZeneca Pharmaceuticals LP | AstraZeneca PLCAstraZeneca Pharmaceuticals LP | AstraZeneca PLC2025-05-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-3200-01ANDEXXA20 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,207
0310-3200-04ANDEXXA4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,47
0310-3200-05ANDEXXA5 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-3200ANDEXXA (ANDEXANET ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTRAZENECA PHARMACEUTICALS LP]6Current NDC, Legacy NDC, 3 package rows20250529_2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-3200-01EA - Each0310-3200ff229d1b-6a1a-4e45-a437-8a286247fc5712023-07-06
0310-3200-04EA - Each0310-3200d1a2a7d5-0134-4840-a80a-cf0c012cbf1e12023-07-06
0310-3200-05EA - Each0310-320044d82298-6374-467e-9ad7-c014baba41d512023-07-06

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 ยท 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
ndc (package): 0310-3200-01
ndc (package): 0310-3200-04
ndc (package): 0310-3200-05
ndc (product): 0310-3200
ndc11 (package): 00310320001
rxcui: 2108128
rxcui: 2108130
spl id: 7c42c928-30f8-44ac-a040-d3087b2d6074
spl set id: 2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c
unii: BI009E452R

Reported adverse events (FAERS/openFDA)#

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