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  5. NDC Package Code: 0310-3200-04 Andexxa

NDC Package 0310-3200-04 Andexxa

Andexanet Alfa Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0310-3200-04
Package Description:
4 VIAL, SINGLE-USE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01)
Product Code:
0310-3200
Proprietary Name:
Andexxa
Non-Proprietary Name:
Andexanet Alfa
Substance Name:
Andexanet Alfa
Usage Information:
ANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers [see Clinical Studies (14)]. An improvement in hemostasis has not been established. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients.
11-Digit NDC Billing Format:
00310320004
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2108128 - coagulation factor Xa (recombinant), inactivated-zhzo 200 MG Injection
  • RxCUI: 2108130 - ANDEXXA 200 MG Injection
  • RxCUI: 2108130 - coagulation factor Xa (recombinant), inactivated-zhzo 200 MG Injection [Andexxa]
  • RxCUI: 2108130 - Andexxa 200 MG Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Astrazeneca Pharmaceuticals Lp
    Dosage Form:
    Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • ANDEXANET ALFA 200 mg/20mL
    • Sample Package:
    No
    FDA Application Number:
    BLA125586
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    07-12-2022
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0310-3200-04 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00310320004J7169Inj andexxa, 10 mg10 MG142080

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0310-3200-055 VIAL, SINGLE-USE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0310-3200-04?

    The NDC Packaged Code 0310-3200-04 is assigned to a package of 4 vial, single-use in 1 carton / 20 ml in 1 vial, single-use (0310-3200-01) of Andexxa, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 0310-3200 included in the NDC Directory?

    Yes, Andexxa with product code 0310-3200 is active and included in the NDC Directory. The product was first marketed by Astrazeneca Pharmaceuticals Lp on July 12, 2022 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0310-3200-04?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 0310-3200-04?

    The 11-digit format is 00310320004. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20310-3200-045-4-200310-3200-04