FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
ANDEXXA

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANDEXANET ALFA200 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBI009E452R
Rxcui2108128, 2108130

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2108130ANDEXXA 200 MG InjectionPSN2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c7
2108128coagulation factor Xa (recombinant), inactivated-zhzo 200 MG InjectionPSN2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c7
2108130coagulation factor Xa (recombinant), inactivated-zhzo 200 MG Injection [Andexxa]SBD2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c7
2108128coagulation factor Xa (recombinant), inactivated-zhzo 200 MG InjectionSCD2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c7
2108130Andexxa 200 MG InjectionSY2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0310-3200-010031032000120 mL in 1 VIAL, SINGLE-USE20 mlHistorical
0310-3200-04003103200044 VIAL, SINGLE-USE in 1 CARTON (0310-3200-04) / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01) 2022-07-122027-12-31NoNoCurrent
0310-3200-05003103200055 VIAL, SINGLE-USE in 1 CARTON (0310-3200-05) / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01) 2023-07-032027-11-30NoNoHistorical