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ANDEXXA andexanet alfa 200 mg/20mL Injection, Powder, Lyophilized, For Solution — NDC 0310-3200-04 (Billing 00310-3200-04)

by AstraZeneca Pharmaceuticals LP · 4 VIAL, SINGLE-USE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-USE

This is a package of ANDEXXA andexanet alfa 200 mg/20mL Injection, Powder, Lyophilized, For Solution from AstraZeneca Pharmaceuticals LP, marketed since Jul 2022 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00310-3200-04
🏷️ FDA NDC (as labeled) 0310-3200-04 billing pads the labeler segment with a zero
This package
Contains20 mL in 1 vial, single-use Pack sizes2 compare ↓
Main listing for product 0310-3200 · Also comes in: 5 vials 0310-3200-05
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0310-3200-04 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0310 labeler · 3200 product · 04 package
Package marketed since
Jul 12, 2022
Package marketing ended
Dec 31, 2027
Sample package
No — commercial package
Barcode (UPC-A, from the NDC)
3 0310320004 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0310-3200-04
Product NDC 0310-3200
11-digit billing NDC 00310320004
NCPDP billing unit EA — each (per item)
RxCUI 2108128, 2108130
UNII BI009E452R
Application # BLA125586
SPL Set ID 2d9d90a6-63e6-46ef-96ff-dd6519ae7b6c
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-07-12
Marketing end 2027-12-31
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance ANDEXANET ALFA
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 079424
GCN 45915
HICL code 044899
Ingredient (HICL) Factor Xa,Inactivated-Zhzo
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M9
Therapeutic class — intermediate (HIC2) Drugs Given To Alter Blood Coagulation
HIC3 code M9Y
Therapeutic class — specific (HIC3) Anticoagulant Reversal Agent For Factor Xa Inhib.
AHFS code 20:28.16.00
AHFS class Hemostatics
FDB label name ANDEXXA 200 MG VIAL
FDB brand name Andexxa
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 079424
  • GCN: 45915
  • HICL (First Databank): 044899
  • AHFS class code: 20:28.16.00
  • RxCUI (RxNorm): 2108128
Why two NDCs? The FDA registers this code as 0310-3200-04 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00310-3200-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Antidotes class.

Drug family (ATC) Antidotes
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ANDEXXA 200 MG VIAL Ingredient Factor Xa,Inactivated-Zhzo

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 5 vials
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00310-3200-04 You're viewing this Main listing 4 VIAL, SINGLE-USE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-USE 2022-07-12 — Active
00310-3200-05 0310-3200-05 5 VIAL, SINGLE-USE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-USE 2023-07-03 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 4 vial, single-use in 1 carton / 20 ml in 1 vial, single-use.
What NDC number is used to bill for this package of ANDEXXA andexanet alfa 200 mg/20mL Injection, Powder, Lyophilized, For Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Andexxa 200 mg/20mLthis 00310-3200-04 AstraZeneca 4 vials — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2018
First FDA approval
May 2018
📍
2026
Currently FDA-listed
8 years listed
🛡️
2030
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through May 2030. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved May 3, 2018 ⏳ ~3.6 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2018 2020 2022 2024 2026 2028 2030
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateMay 3, 2030
Common questions
Is there a biosimilar for ANDEXXA 200 MG VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAstraZeneca Pharmaceuticals LP
FDA applicationBLA125586 (BLA)
Labeler code00310
First marketedJul 2022
Product typeHuman Prescription Drug
Portfolio113 products on file

More NDCs from AstraZeneca Pharmaceuticals LP labeler code 00310

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning 150 words ▾

WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including: ( 5.1 ) • Arterial and venous thromboembolic events • Ischemic events, including myocardial infarction and ischemic stroke • Cardiac arrest • Sudden deaths Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.

WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, and SUDDEN DEATHS See full prescribing information for complete boxed warning Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including: ( 5.1 ) • Arterial and venous thromboembolic events • Ischemic events, including myocardial infarction and ischemic stroke • Cardiac arrest • Sudden deaths Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE 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. ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. ( 1 ) This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers.

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. ( 1 , 14 ) Limitations of Use ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban.

( 1 ) Limitations of Use ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For intravenous (IV) use only. • Dose ANDEXXA based on the specific FXa inhibitor, dose of FXa inhibitor, and time since the patient's last dose of FXa inhibitor. ( 2 ) • Administer as an IV bolus, with a target rate of 30 mg/min, followed by continuous infusion for 120 minutes. ( 2.3 ) • There are two dosing regimens: Dose The safety and effectiveness of more than one dose have not been evaluated.

( 2.1 ) Initial IV Bolus Follow-On IV Infusion Low Dose 400 mg at a target rate of 30 mg/min 4 mg/min for 120 minutes High Dose 800 mg at a target rate of 30 mg/min 8 mg/min for 120 minutes

2.1Dose For intravenous (IV) use only. There are two dosing regimens (see Table 1 ). The safety and efficacy of an additional dose have not been established.

Table 1: ANDEXXA Dosing Regimens Dose The safety and effectiveness of more than one dose have not been evaluated. Initial IV Bolus Follow-On IV Infusion Total Number of 200 mg Vials Low Dose 400 mg at a target rate of 30 mg/min 4 mg/min for 120 minutes (480 mg) 5 (2 vials bolus + 3 vials infusion) High Dose 800 mg at a target rate of 30 mg/min 8 mg/min for 120 minutes (960 mg) 9 (4 vials bolus + 5 vials infusion) The recommended dosing of ANDEXXA is based on the specific FXa inhibitor, dose of FXa inhibitor, and time since the patient's last dose of FXa inhibitor (see Table 2 ).

Table 2: ANDEXXA Dose Based on Rivaroxaban or Apixaban Dose (Timing of Last Dose of FXa Inhibitor before ANDEXXA Initiation) FXa Inhibitor FXa Inhibitor Last Dose < 8 Hours or Unknown ≥ 8 Hours Rivaroxaban ≤ 10 mg Low Dose Low Dose > 10 mg or Unknown High Dose Apixaban ≤ 5 mg Low Dose > 5 mg or Unknown High Dose

2.2Reconstitution • The reconstituted solution contains coagulation factor Xa (recombinant), inactivated-zhzo at a concentration of 10 mg/mL. • Reconstituted ANDEXXA in vials is stable at room temperature for up to eight hours, or may be stored for up to 24 hours at 2°C to 8°C (36°F to 46°F). • Reconstituted ANDEXXA in IV bags is stable at room temperature for up to eight hours. IV Bolus Preparation Determine total number of vials required (see Table 1 ). 200 mg vials: Reconstitute the 200 mg vial of ANDEXXA with 20 mL of Sterile Water for Injection (SWFI).

Use a 20-mL (or larger) syringe and 20-gauge (or smaller in diameter, e.g., 21-gauge) needle. Slowly inject the SWFI, directing the solution onto the inside wall of the vial to minimize foaming. To reduce the total reconstitution time needed during preparation, reconstitute all required vials in succession.

To ensure dissolution of the cake or powder, gently swirl each vial until complete dissolution of powder occurs (A). Do not shake (B); shaking could lead to foaming. Typical dissolution time for each vial is approximately three to five minutes.

If dissolution is incomplete, discard the vial, and do not use the product. Upon reconstitution, the parenteral drug product should be inspected visually for particulate matter and discoloration prior to administration. (A) (B) Use 40-mL (or larger) syringe with a 20-gauge (or smaller in diameter, e.g., 21-gauge) needle to withdraw the reconstituted ANDEXXA solution from each of the vials until the required dosing volume is achieved.

Note the total volume withdrawn into the syringe. Transfer the ANDEXXA solution from the syringe into an empty polyolefin or polyvinyl chloride IV bag with a volume of 250 mL or less. Discard the syringe and needle.

Discard the vials, including any unused portion. Figure figure a figure B figure II Continuous IV Infusion Preparation • Follow the same procedure outlined above for IV bolus preparation. Reconstitute the total number of vials needed based on the dose requirements.

More than one 40 to 60 mL syringe, or an equivalent 100-mL syringe, may be used for transfer of reconstituted solution to the IV bag. • Infusion will require a 0.2 or 0.22 micron in-line polyethersulfone or equivalent low protein-binding filter.

2.3 Administration • Upon reconstitu…

💊 Dosage Forms and Strengths 49 words ▾

3 DOSAGE FORMS AND STRENGTHS ANDEXXA is available as a white to off-white lyophilized powder in single-dose vials of 200 mg of coagulation factor Xa (recombinant), inactivated-zhzo. ANDEXXA is available as a lyophilized powder in single-dose vials of 200 mg of coagulation factor Xa (recombinant), inactivated-zhzo. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Arterial and venous thromboembolic events, ischemic events, and cardiac events, including sudden death, have occurred during treatment with ANDEXXA. Resume anticoagulant therapy as soon as medically appropriate following treatment with ANDEXXA . ( 5.1 ) • Unresponsiveness to unfractionated heparin has been reported following ANDEXXA administration.

( 5.2 ) • Re-elevation or incomplete reversal of anticoagulant activity can occur. ( 5.3 )

5.1Thromboembolic and Ischemic Risks The thromboembolic and ischemic risks were assessed in 419 bleeding -patients in the ANNEXA-4 study who received ANDEXXA and were treated with apixaban or rivaroxaban. There were 45/419 (10.7%) patients who experienced a thrombotic event. The median time to first event was 10 days, and 17 patients experienced the event within three days of treatment.

Of the 419 patients who received ANDEXXA, 266 received at least one anticoagulation dose within 30 days after treatment as a prophylactic measure. Of these 266 patients, 14 patients (5.3%) had a thrombotic event after resumption [ see Adverse Reactions (6.1) ]. Monitor patients treated with ANDEXXA for signs and symptoms of arterial and venous thromboembolic events, ischemic events, and cardiac arrest.

To reduce thromboembolic risk, resume anticoagulant therapy as soon as medically appropriate following treatment with ANDEXXA [ see Dosage and Administration (2.4) ]. The safety of ANDEXXA has not been evaluated in patients who experienced thromboembolic events or disseminated intravascular coagulation within two weeks prior to the life-threatening bleeding event requiring treatment with ANDEXXA. Safety of ANDEXXA also has not been evaluated in patients who received prothrombin complex concentrates, recombinant factor VIIa, or whole blood products within seven days prior to the bleeding event.

5.2Unresponsiveness to Unfractionated Heparin Unresponsiveness to unfractionated heparin leading to non-prolongation of activated clotting times and serious thrombotic events has occurred following ANDEXXA administration. [ see Postmarketing Experience (6.2) ]. Do not use ANDEXXA for the reversal of direct FXa inhibitors (apixaban and rivaroxaban) prior to heparinization. If anticoagulation is needed, use an alternative anticoagulant to heparin Use of ANDEXXA as an antidote for heparin has not been established.

5.3Re-elevation or Incomplete Reversal of Anti-FXa Activity The time course of anti-FXa activity following ANDEXXA administration was consistent among the healthy volunteer studies and the ANNEXA-4 study in bleeding patients [ see Clinical Studies (14) ]. Compared to baseline, there was a rapid and substantial decrease in anti-FXa activity corresponding to the ANDEXXA bolus. This decrease was sustained through the end of the ANDEXXA continuous infusion.

The anti-FXa activity returned to the placebo levels approximately two hours after completion of a bolus or continuous infusion. Subsequently, the anti-FXa activity decreased at a rate similar to the clearance of the FXa inhibitors. A total of 114 patients from ANNEXA-4 were anticoagulated with apixaban or rivaroxaban and had elevated baseline levels of anti-FXa (>150 ng/mL for apixaban and >300 ng/mL for rivaroxaban).

After administration of ANDEXXA, these patients experienced decreased anti-FXa activity levels, with median reductions of 96% for rivaroxaban and 92% for apixaban .

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (≥ 5%) in bleeding patients receiving ANDEXXA were urinary tract infections and pneumonia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most common adverse reactions (≥ 5%) in bleeding patients receiving ANDEXXA were urinary tract infections and pneumonia. In Study 3 (ANNEXA-4), four hundred and seventy-seven patients with acute major bleeding were enrolled and received ANDEXXA.

Of these 477 patients, 419 patients were treated with apixaban (245/419; 58.5%) or rivaroxaban (174/419; 41.5%). Most patients had received apixaban or rivaroxaban as anticoagulation treatment for atrial fibrillation (348/419; 83%) or venous thromboembolism (65/419; 16%). In the majority of patients, ANDEXXA was used to reverse anticoagulant therapy following either an intracranial hemorrhage (289/419; 69%) or a gastrointestinal bleed (95/419; 23%), with the remaining patients (35/419; 8.4%) experiencing bleeding at other sites.

Patients were assessed at a Day 30 follow-up visit following infusion with ANDEXXA. Deaths In the ANNEXA-4 study, of the 419 patients in the safety population who were treated with apixaban or rivaroxaban, there were 75 deaths (18%). There were 37 cardiovascular deaths related to bleeding, 19 deaths that were cardiovascular and not related to bleeding, 14 that were non-cardiovascular, and 5 deaths had an uncertain or unknown cause.

The average time to death was 15 days after treatment. All patients died prior to Day 45. Of the 75 patients who died, the initial bleeding event was intracranial bleeding in 55 (73%), gastrointestinal bleeding in 14 (19%), and other bleeding types in 6 (8%)patients.

Thromboembolic and Ischemic Events In the Study 3 (ANNEXA-4), 45/419 (10.7%) patients experienced one or more of the following thromboembolic events: cerebrovascular accident (CVA) (19/45; 42%), deep venous thrombosis (11/45; 24%), myocardial infarction (9/45; 20%), pulmonary embolism (5/45; 11%), and transient ischemic attack (1/45; 2%). The median time to event was ten days. A total of 38% of patients with thromboembolic events (17/45) experienced the thromboembolic event during the first three days.

Of the 419 patients who received ANDEXXA, 282 (67.3%) received any form of re-anticoagulation within 30 days after treatment. Of these 282 patients, 16 received anticoagulation in response to a thrombotic event, while 266 received the anticoagulation as a prophylactic. Of these 266, 14 patients (5.3%) had a thrombotic event after resumption of anticoagulation; while of the 153 patients who did not receive anticoagulation as a prophylactic, 31 (20.3%) had a thrombotic event.

No patient had a thrombotic event after resumption of oral anticoagulation [ see Warnings and Precautions (5.1) ]. Infusion-Related Reactions In the ANNEXA-4 study, 2/419 (0.5%) patients experienced an infusion-related reaction, neither of which were assessed as severe (1 moderate; 1 mild). Reported signs and symptoms were transient and included rigors, chills, hypertension, oxygen desaturation, agitation and confusion.

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of ANDEXXA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or stablish a causal relationship to drug exposure. General disorders and administration site conditions: heparin resistance [ see Unresponsiveness to Unfractionated Heparin (5.2) ] and [ see Use with Unfractionated Heparin (7.1) ].

🔄 Drug Interactions 137 words ▾

7 DRUG INTERACTIONS Do not use unfractionated heparin following ANDEXXA administration due to unresponsiveness characterized by non-prolongation of activated clotting times ( 7.1 ). See full prescribing information for details on drug interactions.

7.1Use with Unfractionated Heparin Unresponsiveness to unfractionated heparin has occurred following ANDEXXA administration, characterized by non-prolongation of activated clotting times and requirement for increased dosing of heparin. Do not use unfractionated heparin following ANDEXXA administration.

7.2Interference with Anti-FXa Activity Test Current commercial clinical anti-FXa-activity assays are unsuitable for measuring FXa activity following administration of ANDEXXA. Due to the reversible binding of ANDEXXA to the FXa inhibitor, the high sample dilution currently used in commercial clinical assays promotes dissociation of the inhibitor from ANDEXXA, resulting in detection of erroneously elevated anti-FXa activity levels, thereby causing a underestimation of the reversal activity of ANDEXXA.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of ANDEXXA in pregnant women to inform patients of associated risks. Animal reproductive and developmental studies have not been conducted with ANDEXXA. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Labor or Delivery The safety and effectiveness of ANDEXXA during labor and delivery have not been evaluated.

8.2Lactation Risk Summary There is no information regarding the presence of ANDEXXA in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ANDEXXA and any potential adverse effects on the breastfed child from ANDEXXA or from the underlying maternal condition.

8.4Pediatric Use The safety and efficacy of ANDEXXA in the pediatric population have not been studied.

8.5Geriatric Use Of the 419 patients in the ANNEXA-4 study of ANDEXXA, 381 (91%) were 65 years of age or older, and 278 (66%) were older than 75 years of age. No overall differences in safety or efficacy were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between elderly and younger patients; however, greater sensitivity of some older individuals cannot be ruled out.

🤰 Pregnancy 78 words ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of ANDEXXA in pregnant women to inform patients of associated risks. Animal reproductive and developmental studies have not been conducted with ANDEXXA. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Labor or Delivery The safety and effectiveness of ANDEXXA during labor and delivery have not been evaluated.

🧒 Pediatric Use 17 words ▾

8.4Pediatric Use The safety and efficacy of ANDEXXA in the pediatric population have not been studied.

🧓 Geriatric Use 74 words ▾

8.5Geriatric Use Of the 419 patients in the ANNEXA-4 study of ANDEXXA, 381 (91%) were 65 years of age or older, and 278 (66%) were older than 75 years of age. No overall differences in safety or efficacy were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between elderly and younger patients; however, greater sensitivity of some older individuals cannot be ruled out.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Coagulation factor Xa (recombinant), inactivated-zhzo exerts its procoagulant effect by binding and sequestering the FXa inhibitors, rivaroxaban and apixaban. Another observed procoagulant effect of the ANDEXXA protein is its ability to bind to, and inhibit the activity of, Tissue Factor Pathway Inhibitor (TFPI). Inhibition of TFPI activity can increase tissue factor (TF)-initiated thrombin generation.

12.2Pharmacodynamics The effects of ANDEXXA can be measured using assays for its anti-FXa activity, free fraction of FXa inhibitor, and thrombin generation. In addition to its ability to sequester the FXa inhibitors, rivaroxaban and apixaban, ANDEXXA has been shown to inhibit TFPI activity. The dose and dosing regimen of ANDEXXA that are required to reverse anti-FXa activity and to restore thrombin generation were determined in dose-ranging studies on healthy volunteers.

Dosing of ANDEXXA, as a bolus followed by a two-hour continuous infusion, resulted in a rapid decrease in anti-FXa activity (within two minutes after the completion of the bolus administration) followed by reduced anti-FXa activity that was maintained throughout the duration of the continuous infusion [see Clinical Studies (14) ] . The anti-FXa activity returned to the placebo levels approximately two hours after completion of a bolus or continuous infusion, whereas TFPI activity in plasma returned to the pretreatment levels approximately 96 hours following ANDEXXA administration.

Elevation of TF-initiated thrombin generation above the baseline range (prior to anticoagulation) occurred within two minutes following a bolus administration of ANDEXXA and was maintained throughout the duration of the continuous infusion. The TF-initiated thrombin generation was elevated above placebo for at least 22 hours. The sustained elevation of thrombin generation over the baseline range and the sustained elevation over placebo were not observed in a contact-activated thrombin generation assay (an assay that is not affected by TF-TFPI interaction).

Laboratory assessment of coagulation does not necessarily correlate with or predict the hemostatic effectiveness of ANDEXXA.

12.3Pharmacokinetics A summary of the pharmacokinetic (PK) properties of ANDEXXA in healthy patients is shown in the table below (see Table 3 ). Table 3: Summary of PK Parameters with High and Low Doses Low Dose High Dose Data presented are geometric mean (Geometric Mean % Coefficient of Variation), [range]. n 11 10 AUC 0-∞ (hr*µg/mL) 200.5 (16.3) [153.4; 255.6] 572.9 (16.0) [467.1; 783.9] C max (µg/mL) 76.6 (17.5) [61.1; 100.1] 206.6 (18.8) [158.9; 280.5] Clearance (L/hr) 4.4 (16.3) [3.4; 5.7] 3.1 (16.0) [2.3; 3.8] T 1/2 (hr) 3.3 (15.0) [2.3; 4.0] 2.7 (20.0) [1.9; 3.4] V ss (L) 4.4 (17.6) [3.3; 5.7] 3.0 (23.3) [2.2; 5.0] Drug-Drug Interaction The pharmacokinetics of ANDEXXA were not affected by apixaban (5 mg orally BID for six days) or rivaroxaban (20 mg orally once daily for six days).

12.6Immunogenicity The observed incidence of anti-drug antibodies (ADAs) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADAs in the studies described below with the incidence of ADAs in other studies, including those of ANDEXXA. Using electrochemiluminescence (ECL)-based assays, 417 ANDEXXA-treated healthy patients were tested for antibodies to ANDEXXA as well as for antibodies cross-reacting with factor X (FX) and FXa.

The analysis of available samples up to Day 48 from pooled healthy patients revealed low incidence of anti-ANDEXXA (≤ 8.7%) and anti-FXa (≤ 0.8%) at all timepoints and no anti-FX antibody was detected at any timepoint. The pattern of immunogenicity in patients with acute major bleeding in the ANNEXA-4 study was similar to that observed in healthy patients. Of the 277 ANDEXXA-treated patients in ANNEXA-4 who had available samples at Day 30 or 45, 7.9% (22/277…

🧬 Mechanism of Action 58 words ▾

12.1Mechanism of Action Coagulation factor Xa (recombinant), inactivated-zhzo exerts its procoagulant effect by binding and sequestering the FXa inhibitors, rivaroxaban and apixaban. Another observed procoagulant effect of the ANDEXXA protein is its ability to bind to, and inhibit the activity of, Tissue Factor Pathway Inhibitor (TFPI). Inhibition of TFPI activity can increase tissue factor (TF)-initiated thrombin generation.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a white to off-white lyophilized cake or powder supplied as single-dose vials in a carton. ANDEXXA is not made with natural rubber latex. ANDEXXA vials are provided as follows (see Table 5): Table 5: Presentation of ANDEXXA NDC Carton Configuration Vial Cap Color Packaging Color NDC 0310-3200-04 4 single use vials in a carton, each vial containing 200 mg of ANDEXXA Vials have a red flip-off cap.

1. Carton and vial label have a red to blue transition colored stripe across the front. 2.

Carton and label have "200 mg/vial" in a blue graphic on the front panel. NDC 0310-3200-05 5 single use vials in a carton, each vial containing 200 mg of ANDEXXA Storage and Handling Prior to reconstitution Unopened vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F) until the expiration date indicated on the label. DO NOT FREEZE.

Do not use ANDEXXA after the expiration date. After reconstitution • Reconstituted ANDEXXA in vials is stable at room temperature for up to 8 hours, or may be stored for up to 24 hours at 2°C to 8°C (36°F to 46°F). • Reconstituted ANDEXXA in IV bags is stable at room temperature for up to 8 hours. • Discard any unused portion of reconstituted solution.

📦 Storage and Handling 95 words ▾

Storage and Handling Prior to reconstitution Unopened vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F) until the expiration date indicated on the label. DO NOT FREEZE. Do not use ANDEXXA after the expiration date.

After reconstitution • Reconstituted ANDEXXA in vials is stable at room temperature for up to 8 hours, or may be stored for up to 24 hours at 2°C to 8°C (36°F to 46°F). • Reconstituted ANDEXXA in IV bags is stable at room temperature for up to 8 hours. • Discard any unused portion of reconstituted solution.

📋 Description 184 words ▾

11 DESCRIPTION ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a sterile, white to off-white lyophilized powder available in single-dose vials. Each 200 mg vial delivers 200 mg of coagulation factor Xa formulated with the inactive ingredients tromethamine (Tris base), Tris hydrochloride, L-arginine hydrochloride, sucrose (1% w/v), mannitol (2.5% w/v), and polysorbate 80 (0.01% w/v) at pH 7.8. After reconstitution of the lyophilized powder with SWFI for IV administration, the product is a clear, colorless to slightly yellow solution.

ANDEXXA contains no preservatives. The active ingredient in ANDEXXA is a genetically modified variant of human FXa. The active site serine was substituted with alanine, rendering the molecule unable to cleave and activate prothrombin.

The gamma-carboxyglutamic acid (Gla) domain was removed to eliminate the protein's ability to assemble into the prothrombinase complex, thus removing the potential anticoagulant effects. No additives of human or animal origin are used in the manufacture of ANDEXXA. The recombinant protein is produced in a genetically engineered Chinese Hamster Ovary (CHO) cell expression system and has a molecular weight of approximately 41 kDa.

The manufacturing process incorporates two validated virus clearance steps.

💬 Information for Patients 90 words ▾

17 PATIENT COUNSELING INFORMATION Discuss following with the patient and /or caregivers: • Thromboembolic and Ischaemic Risks: Inform patients and/or caregivers that the reversing of FXa inhibitor therapy increases the risk of thromboembolic events. Arterial and venous thromboembolic events, ischemic events, cardiac events, and sudden death were observed within 30 days following ANDEXXA administration.[ see Warnings and Precautions (5.1) ]. • Unresponsiveness to Unfractionated Heparin: Inform patients and/or caregivers that unresponsiveness to unfractionated heparin and serious thrombotic events have occurred following ANDEXXA administration. [ see Warnings and Precautions (5.2) ].

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ANDEXXA (this brand).

Top reported reactions

Death124
Cerebral Infarction54
Acute Myocardial Infarction37
Cerebral Haemorrhage36
Ischaemic Stroke36
Heparin Resistance34
Pulmonary Embolism34

Age at onset

Neonate1
Adult31
Elderly147

Reporter sex

708 reports
Male · 55%
Female · 45%
Unknown · 1%

Serious outcomes

Death321
Hospitalization174
Life-threatening116
Disabling45
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 179 16
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but AstraZeneca Pharmaceuticals LP has reported a marketing end date of 2027-12-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 5 vials (00310-3200-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
AstraZeneca Pharmaceuticals LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.