andexxa

Generic: andexanet alfa

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name andexxa
Generic Name andexanet alfa
Labeler astrazeneca pharmaceuticals lp
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

andexanet alfa 200 mg/20mL

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-3200
Product ID 0310-3200_d77f3b2f-eda8-45ae-8455-0fc1694fcd54
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125586
Listing Expiration 2026-12-31
Marketing Start 2022-07-12

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03103200
Hyphenated Format 0310-3200

Supplemental Identifiers

RxCUI
2108128 2108130
UNII
BI009E452R

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name andexxa (source: ndc)
Generic Name andexanet alfa (source: ndc)
Application Number BLA125586 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/20mL
source: ndc
Packaging
  • 4 VIAL, SINGLE-USE in 1 CARTON (0310-3200-04) / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01)
  • 5 VIAL, SINGLE-USE in 1 CARTON (0310-3200-05) / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01)
source: ndc

Packages (2)

0310-3200-04 4 VIAL, SINGLE-USE in 1 CARTON (0310-3200-04) / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01) 0310-3200-05 5 VIAL, SINGLE-USE in 1 CARTON (0310-3200-05) / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01)

Ingredients (1)

andexanet alfa (200 mg/20mL)

Linked Drug Pages (1)

ANDEXXA ndc-match (0.9)

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"}