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United States · US · US:0310-3200_7c42c928-30f8-44ac-a040-d3087b2d6074
ANDEXXA
UNIISPLATC V03AB38
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeV03AB38
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1103103200044 VIAL, SINGLE-USE in 1 CARTON (0310-3200-04) / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01)
- ndc1103103200055 VIAL, SINGLE-USE in 1 CARTON (0310-3200-05) / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01)
Annotations
UNII (FDA Substance ID)
BI009E452R
ANDEXANET ALFA
RxCUI 2045114
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "BI009E452R",
"rxcui": "2045114",
"inchikey": null,
"display_name": "ANDEXANET ALFA",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c": {
"match": "brand_token",
"title": "ANDEXXA (ANDEXANET ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTRAZENECA PHARMACEUTICALS LP]",
"spl_version": "7",
"published_date": "2026-04-28"
}
},
"productid": "0310-3200_7c42c928-30f8-44ac-a040-d3087b2d6074",
"productndc": "0310-3200",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ANDEXANET ALFA",
"proprietary_name": "ANDEXXA",
"active_ingred_unit": "mg/20mL",
"application_number": "BLA125586",
"marketing_category": "BLA",
"nonproprietary_name": "andexanet alfa",
"start_marketing_date": "20220712",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code V03AB38.
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