Package 0310-3200-04

Brand: andexxa

Generic: andexanet alfa
NDC Package

Package Facts

Identity

Package NDC 0310-3200-04
Digits Only 0310320004
Product NDC 0310-3200
Description

4 VIAL, SINGLE-USE in 1 CARTON (0310-3200-04) / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01)

Marketing

Marketing Status
Marketed Since 2022-07-12
Brand andexxa
Generic andexanet alfa
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "d77f3b2f-eda8-45ae-8455-0fc1694fcd54", "openfda": {"unii": ["BI009E452R"], "rxcui": ["2108128", "2108130"], "spl_set_id": ["2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 VIAL, SINGLE-USE in 1 CARTON (0310-3200-04)  / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01)", "package_ndc": "0310-3200-04", "marketing_start_date": "20220712"}, {"sample": false, "description": "5 VIAL, SINGLE-USE in 1 CARTON (0310-3200-05)  / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01)", "package_ndc": "0310-3200-05", "marketing_start_date": "20230703"}], "brand_name": "ANDEXXA", "product_id": "0310-3200_d77f3b2f-eda8-45ae-8455-0fc1694fcd54", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "product_ndc": "0310-3200", "generic_name": "andexanet alfa", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ANDEXXA", "active_ingredients": [{"name": "ANDEXANET ALFA", "strength": "200 mg/20mL"}], "application_number": "BLA125586", "marketing_category": "BLA", "marketing_start_date": "20220712", "listing_expiration_date": "20261231"}