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Cathflo Activase Alteplase 2.2 mg/2mL Injection, Powder, Lyophilized, For Solution — NDC 50242-0041-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cathflo Activase Alteplase 2.2 mg/2mL Injection, Powder, Lyophilized, For Solution — NDC 50242-041-10 (Billing 50242-0041-10)

by Genentech, Inc. · 10 VIAL in 1 CARTON / 2 mL in 1 VIAL

This is a package of Cathflo Activase Alteplase 2.2 mg/2mL Injection, Powder, Lyophilized, For Solution from Genentech, Inc., marketed since Sep 2001 and currently FDA-listed.

NDC 50242-0041-10
🏷️ FDA NDC (as labeled) 50242-041-10 billing pads the product segment with a zero
This package
Contains2 mL in 1 vial Medicaid pays$157.46 / unit · 12 mo Per package$3,149.12 / 20 ml · Medicaid Pack sizes2 compare ↓
Product page 50242-0041-64 Also comes in: 2 mL 50242-041-64
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 →

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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 50242-041-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50242 labeler · 041 product · 10 package
Package marketed since
Oct 14, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5024204110 2
Medicaid fills, this package
528 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
Past resolved recalls for this product (1)
Class II · May 20, 2024 · Terminated — Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase. (Genentech, Inc.) · FDA recall D-0509-2024

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50242-041-10
Product NDC 50242-041
11-digit billing NDC 50242004110
NCPDP billing unit EA — each (per item)
UNII 1RXS4UE564
Application # BLA103172
SPL Set ID 91ecdef2-95ff-42dd-a31c-c8a09cab3ad9
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2001-09-04
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance ALTEPLASE
Biologic (Purple Book) 351(a)

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

GPI-14 85601010002102
GPI class Cathflo Activase
GCN Seq No 048447
GCN 13922
HICL code 002803
Ingredient (HICL) Alteplase
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M9
Therapeutic class — intermediate (HIC2) Drugs Given To Alter Blood Coagulation
HIC3 code M9F
Therapeutic class — specific (HIC3) Thrombolytic Enzymes
AHFS code 20:12.20.00
AHFS class Thrombolytic Agents
FDB label name CATHFLO ACTIVASE 2 MG VIAL
FDB brand name Cathflo Activase
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 048447
  • GCN: 13922
  • GPI-14 (Medi-Span): 85601010002102
  • HICL (First Databank): 002803
  • AHFS class code: 20:12.20.00
Why two NDCs? The FDA registers this code as 50242-041-10 — a 5-3-2 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 product segment → 50242-0041-10. 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.

Clinical

Label name CATHFLO ACTIVASE 2 MG VIAL Ingredient Alteplase

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 $157.46 $3,149.12 / 20 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2997 $98.587 / J2997 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)50242-041-10
11-digit billing NDC50242-0041-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2997
DescriptorINJECTION, ALTEPLASE RECOMBINANT, 1 MG
Billing units / pkg2 units
How the units are derivedThis package is 10 EA; the HCPCS unit is 1 MG, so one package = 2 billing units.
Medicare Part B spend (2026 (Q1))$3,490,673 · 13,490 claims · $258.76 per claim (all NDCs under J2997)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
50242-0041-10 You're viewing this 10 VIAL in 1 CARTON / 2 mL in 1 VIAL — — 2019-10-14 — Active
50242-0041-64 50242-041-64 Main listing 1 VIAL in 1 CARTON / 2 mL in 1 VIAL $186.38 / ea $186.38 2001-09-04 — Active

This pack accounts for about 1.8% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 10 vial in 1 carton / 2 ml in 1 vial.
What NDC number is used to bill for this package of Cathflo Activase Alteplase 2.2 mg/2mL 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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cathflo Activase 2.2 mg/2mLthis 50242-0041-10 Genentech, 10 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

🏛️
1987
First FDA approval
Nov 1987
📍
2026
Currently FDA-listed
39 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

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

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Activasealteplase Cathflo Activasealteplase
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 77 mg / 2 mL UNII 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
  • UNII E4GA8884NN
    Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
  • 0.2 mg / 2 mL UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerGenentech, Inc.
FDA applicationBLA103172 (BLA)
Labeler code50242
First marketedSep 2001
Product typeHuman Prescription Drug
Portfolio93 products on file

More NDCs from Genentech, Inc. labeler code 50242

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

INDICATIONS AND USAGE Cathflo ® Activase ® (Alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Cathflo ® Activase ® (Alteplase) is for instillation into the dysfunctional catheter at a concentration of 1 mg/mL. • Patients weighing ≥30 kg: 2 mg in 2 mL • Patients weighing <30 kg: 110% of the internal lumen volume of the catheter, not to exceed 2 mg in 2 mL If catheter function is not restored at 120 minutes after 1 dose of Cathflo Activase, a second dose may be instilled (see Instructions for Administration ). There is no efficacy or safety information on dosing in excess of 2 mg per dose for this indication.

Studies have not been performed with administration of total doses greater than 4 mg (two 2‑mg doses). Instructions for Administration Preparation of Solution Reconstitute Cathflo Activase to a final concentration of 1 mg/mL: Aseptically withdraw 2.2 mL of Sterile Water for Injection, USP (diluent is not provided). Do not use Bacteriostatic Water for Injection.

Inject the 2.2 mL of Sterile Water for Injection, USP, into the Cathflo Activase vial, directing the diluent stream into the powder. Slight foaming is not unusual; let the vial stand undisturbed to allow large bubbles to dissipate. Mix by gently swirling until the contents are completely dissolved.

Complete dissolution should occur within 3 minutes. DO NOT SHAKE. The reconstituted preparation results in a colorless to pale yellow transparent solution containing 1 mg/mL Cathflo Activase at a pH of approximately 7.3.

Cathflo Activase contains no antibacterial preservatives and should be reconstituted immediately before use. The solution may be used for intracatheter instillation within 8 hours following reconstitution when stored at 2–30°C (36–86°F). No other medication should be added to solutions containing Cathflo Activase.

Instillation of Solution into the Catheter Inspect the product prior to administration for foreign matter and discoloration. Withdraw 2 mL (2 mg) of solution from the reconstituted vial. Instill the appropriate dose of Cathflo Activase (see DOSAGE AND ADMINISTRATION ) into the occluded catheter.

After 30 minutes of dwell time, assess catheter function by attempting to aspirate blood. If the catheter is functional, go to Step 7. If the catheter is not functional, go to Step 5.

After 120 minutes of dwell time, assess catheter function by attempting to aspirate blood and catheter contents. If the catheter is functional, go to Step 7. If the catheter is not functional, go to Step 6.

If catheter function is not restored after one dose of Cathflo Activase, a second dose of equal amount may be instilled. Repeat the procedure beginning with Step 1 under Preparation of Solution. If catheter function has been restored, aspirate 4–5 mL of blood in patients ≥10 kg or 3 mL in patients <10 kg to remove Cathflo Activase and residual clot, and gently irrigate the catheter with 0.9% Sodium Chloride Injection, USP.

Any unused solution should be discarded . Stability and Storage Store lyophilized Cathflo Activase at refrigerated temperature (2–8°C/36–46°F). Do not use beyond the expiration date on the vial.

Protect the lyophilized material during extended storage from excessive exposure to light.

⛔ Contraindications 23 words ▾

CONTRAINDICATIONS Cathflo Activase should not be administered to patients with known hypersensitivity to Alteplase or any component of the formulation (see DESCRIPTION ).

⚠️ Warnings 2 words ▾

WARNINGS None.

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in Section PRECAUTIONS of the label: Bleeding Hypersensitivity In the clinical trials, the most serious adverse events reported after treatment were sepsis (see PRECAUTIONS, Infections ), gastrointestinal bleeding, and venous thrombosis. 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 practice.

Trials 1 and 2 The data described for Trials 1 and 2 reflect exposure to Cathflo Activase in 1122 patients, of whom 880 received a single dose and 242 received two sequential doses of Cathflo Activase. In the Cathflo Activase Trials 1 and 2, only limited, focused types of serious adverse events were recorded, including death, major hemorrhage, intracranial hemorrhage, pulmonary or arterial emboli, and other serious adverse events not thought to be attributed to underlying disease or concurrent illness. Major hemorrhage was defined as severe blood loss ( > 5 mL/kg), blood loss requiring transfusion, or blood loss causing hypotension.

Non‑serious adverse events and serious events thought to be due to underlying disease or concurrent illness were not recorded. Patients were observed for serious adverse events until catheter function was deemed to be restored or for a maximum of 4 or 6 hours depending on study. For most patients the observation period was 30 minutes to 2 hours.

Spontaneously reported deaths and serious adverse events that were not thought to be related to the patient's underlying disease were also recorded during the 30 days following treatment. Four catheter-related sepsis events occurred from 15 minutes to 1 day after treatment with Alteplase, and a fifth sepsis event occurred on Day 3 after Alteplase treatment. All 5 patients had positive catheter or peripheral blood cultures within 24 hours after symptom onset.

Three patients had a major hemorrhage from a gastrointestinal source from 2 to 3 days after Alteplase treatment. One case of injection site hemorrhage was observed at 4 hours after treatment in a patient with pre-existing thrombocytopenia. These events may have been related to underlying disease and treatments for malignancy, but a contribution to occurrence of the events from Alteplase cannot be ruled out.

There were no reports of intracranial hemorrhage. Three cases of subclavian and upper extremity deep venous thrombosis were reported 3 to 7 days after treatment. These events may have been related to underlying disease or to the long-term presence of an indwelling catheter, but a contribution to occurrence of the events from Alteplase treatment cannot be ruled out.

There were no reports of pulmonary emboli. There were no gender-related differences observed in the rates of adverse reactions. Adverse reactions profiles were similar across all age subgroups.

Trial 3 In Trial 3 all serious adverse events were recorded with a specific interest in intracranial hemorrhage, major hemorrhage, thrombosis, embolic events, sepsis and catheter related complications. Major hemorrhage was defined as severe blood loss ( > 5 mL/kg), blood loss requiring transfusion, or blood loss causing hypotension. Non-serious adverse events were not recorded.

Patients were observed until catheter function was deemed to be restored or for a maximum of 4 hours after the first dose. Additionally, serious adverse events were elicited from patients at 48 hours (up to 96 hours) following completion of treatment. No pediatric patients in Trial 3 experienced an intracranial hemorrhage, major hemorrhage, thrombosis, or an embolic event.

Three cases of sepsis occurred 2 to 44 hours after treatment with Cathflo Activase. All of these patients had evidence of infection prior to administration of Cathflo Activase. An additional patient developed fever and lethargy within… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 28 words ▾

Drug Interactions The interaction of Cathflo Activase with other drugs has not been formally studied. Concomitant use of drugs affecting coagulation and/or platelet function has not been studied.

🔄 Drug / Laboratory Test Interactions 15 words ▾

Drug/Laboratory Test Interactions Potential interactions between Cathflo Activase and laboratory tests have not been studied.

🤰 Pregnancy 103 words ▾

Pregnancy Alteplase has been shown to have an embryocidal effect due to an increased postimplantation loss rate in rabbits when administered intravenously during organogenesis at a dose (3 mg/kg) approximately 50 times human exposure (based on AUC) at the dose for restoration of function to occluded CVADs. No maternal or fetal toxicity was evident at a dose (1 mg/kg) approximately 16 times human exposure at the dose for restoration of function to occluded CVADs. There are no adequate and well‑controlled studies in pregnant women.

Cathflo Activase should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 39 words ▾

Pediatric Use A total of 432 subjects under age 17 have received Cathflo Activase in the three trials. Rates of serious adverse events were similar in the pediatric and adult patients, as were the rates of catheter function restoration.

🧓 Geriatric Use 81 words ▾

Geriatric Use In 312 patients enrolled who were age 65 years and over, no incidents of intracranial hemorrhage (ICH), embolic events, or major bleeding events were observed. One hundred three of these patients were age 75 years and over, and 12 were age 85 years and over. The effect of Alteplase on common age-related comorbidities has not been studied.

In general, caution should be used in geriatric patients with conditions known to increase the risk of bleeding (see PRECAUTIONS, Bleeding ).

🧬 Clinical Pharmacology 173 words ▾

CLINICAL PHARMACOLOGY Alteplase is an enzyme (serine protease) that has the property of fibrin-enhanced conversion of plasminogen to plasmin. It produces limited conversion of plasminogen in the absence of fibrin. Alteplase binds to fibrin in a thrombus and converts the entrapped plasminogen to plasmin, thereby initiating local fibrinolysis (1).

In patients with acute myocardial infarction administered 100 mg of Activase as an accelerated intravenous infusion over 90 minutes, plasma clearance occurred with an initial half‑life of less than 5 minutes and a terminal half‑life of 72 minutes. Clearance is mediated primarily by the liver (2). When Cathflo Activase is administered for restoration of function to central venous access devices according to the instructions in DOSAGE AND ADMINISTRATION, circulating plasma levels of Alteplase are not expected to reach pharmacologic concentrations.

If a 2 mg dose of Alteplase were administered by bolus injection directly into the systemic circulation (rather than instilled into the catheter), the concentration of circulating Alteplase would be expected to return to endogenous circulating levels of 5–10 ng/mL within 30 minutes (1).

📦 How Supplied / Storage and Handling 58 words ▾

HOW SUPPLIED Cathflo Activase (Alteplase) for injection is supplied as a sterile, lyophilized powder in 2 mg vials. Cathflo ® Activase ® is available in a carton that contains one 2 mg vial of Cathflo ® Activase ® (Alteplase): NDC 50242‑041‑64 or a carton that contains ten 2 mg vials of Cathflo ® Activase ® (Alteplase): NDC 50242-041-10.

📋 Description 162 words ▾

DESCRIPTION Cathflo ® Activase ® (Alteplase) is a tissue plasminogen activator (t‑PA) produced by recombinant DNA technology. It is a sterile, purified glycoprotein of 527 amino acids. It is synthesized using the complementary DNA (cDNA) for natural human tissue‑type plasminogen activator (t‑PA) obtained from an established human cell line.

The manufacturing process involves secretion of the enzyme Alteplase into the culture medium by an established mammalian cell line (Chinese hamster ovary cells) into which the cDNA for Alteplase has been genetically inserted. Cathflo Activase (Alteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intracatheter instillation for restoration of function to central venous access devices following reconstitution with Sterile Water for Injection, USP. Each vial of Cathflo Activase contains 2.2 mg of Alteplase (which includes a 10% overfill), 77 mg of L‑arginine, 0.2 mg of polysorbate 80, and phosphoric acid for pH adjustment.

Each reconstituted vial will deliver 2 mg of Cathflo Activase, at a pH of approximately 7.3.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Catheter dysfunction may be caused by a variety of conditions other than thrombus formation, such as catheter malposition, mechanical failure, constriction by a suture, and lipid deposits or drug precipitates within the catheter lumen. These types of conditions should be considered before treatment with Cathflo Activase. Because of the risk of damage to the vascular wall or collapse of soft‑walled catheters, vigorous suction should not be applied during attempts to determine catheter occlusion.

Excessive pressure should be avoided when Cathflo Activase is instilled into the catheter. Such force could cause rupture of the catheter or expulsion of the clot into the circulation. Bleeding The most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding (3,4).

Cathflo Activase has not been studied in patients known to be at risk for bleeding events that may be associated with the use of thrombolytics. Caution should be exercised with patients who have active internal bleeding or who have had any of the following within 48 hours: surgery, obstetrical delivery, percutaneous biopsy of viscera or deep tissues, or puncture of non‑compressible vessels. In addition, caution should be exercised with patients who have thrombocytopenia, other hemostatic defects (including those secondary to severe hepatic or renal disease), or any condition for which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location, or who are at high risk for embolic complications (e.g., venous thrombosis in the region of the catheter).

Death and permanent disability have been reported in patients who have experienced stroke and other serious bleeding episodes when receiving pharmacologic doses of a thrombolytic. Should serious bleeding in a critical location (e.g., intracranial, gastrointestinal, retroperitoneal, pericardial) occur, treatment with Cathflo Activase should be stopped and the drug should be withdrawn from the catheter. Infections Cathflo Activase should be used with caution in the presence of known or suspected infection in the catheter.

Using Cathflo Activase in patients with infected catheters may release a localized infection into the systemic circulation (see ADVERSE REACTIONS ). As with all catheterization procedures, care should be used to maintain aseptic technique. Hypersensitivity Hypersensitivity, including urticaria, angioedema and anaphylaxis, has been reported in association with use of Cathflo Activase.

Monitor patients treated with Cathflo Activase for signs of hypersensitivity and treat appropriately if necessary. Re-Administration In clinical trials, patients received up to two 2 mg/2 mL doses (4 mg total) of Alteplase. Additional re-administration of Cathflo Activase has not been studied.

Antibody formation in patients receiving one or more doses of Cathflo Activase for restoration of function to CVADs has not been studied. Drug Interactions The interaction of Cathflo Activase with other drugs has not been formally studied. Concomitant use of drugs affecting coagulation and/or platelet function has not been studied.

Drug/Laboratory Test Interactions Potential interactions between Cathflo Activase and laboratory tests have not been studied. Carcinogenesis, Mutagenesis, Impairment of Fertility Long‑term studies in animals have not been performed to evaluate the carcinogenic potential or the effect on fertility. Short-term studies that evaluated tumorigenicity of Alteplase and effect on tumor metastases were negative in rodents.

Studies to determine mutagenicity (Ames test) and chromosomal aberration assays in human lymphocytes were negative at all concentrations tested. Cytotoxicity, as reflected by a decrease in mitotic index, was evidenced only after prolonged exposure at high concentrations exceeding those expected to be achieved with Cathflo Activase. Pregnancy Alteplase has been shown to have an embryocidal effect… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 35 words ▾

Nursing Mothers It is not known whether Cathflo Activase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cathflo Activase is administered to a nursing woman.

🔬 Clinical Studies ~3 min read ▾

CLINICAL STUDIES Three clinical studies were performed in patients with improperly functioning central venous access devices (CVADs). A placebo‑controlled, double‑blind, randomized trial (Trial 1) and a larger open‑label trial (Trial 2) investigated the use of Alteplase in predominately adult patients who had an indwelling CVAD for administration of chemotherapy, total parenteral nutrition, or long‑term administration of antibiotics or other medications. Both studies enrolled patients whose catheters were not functioning (defined as the inability to withdraw at least 3 mL of blood from the device) but had the ability to instill the necessary volume of study drug.

Patients with hemodialysis catheters or a known mechanical occlusion were excluded from both studies. Also excluded were patients considered at high risk for bleeding or embolization (see PRECAUTIONS, Bleeding ), as well as patients who were younger than 2 years old or weighed less than 10 kg. Restoration of function was assessed by successful withdrawal of 3 mL of blood and infusion of 5 mL of saline through the catheter.

Trial 1 tested the efficacy of a 2 mg/2 mL Alteplase dose in restoring function to occluded catheters in 150 patients with catheter occlusion up to 24 hours in duration. Patients were randomized to receive either Alteplase or placebo instilled into the lumen of the catheter, and catheter function was assessed at 120 minutes. Restoration of function was assessed by successful withdrawal of 3 mL of blood and infusion of 5 mL of saline through the catheter.

All patients whose catheters did not meet these criteria were then administered Alteplase, until function was restored or each patient had received up to two active doses. After the initial dose of study agent, 51 (67%) of 76 patients randomized to Alteplase and 12 (16%) of 74 patients randomized to placebo had catheter function restored. This resulted in a treatment‑associated difference of 51% (95% CI is 37% to 64%).

A total of 112 (88%) of 127 Alteplase‑treated patients had restored function after up to two doses. Trial 2 was an open‑label, single arm trial in 995 patients with catheter dysfunction and included patients with occlusions present for any duration. Patients were treated with Alteplase with up to two doses of 2 mg/2 mL (less for children who weighed less than 30 kg, see DOSAGE AND ADMINISTRATION ) instilled into the lumen of the catheter.

Assessment for restoration of function was made at 30 minutes after each instillation. If function was not restored, catheter function was re‑assessed at 120 minutes. Thirty minutes after instillation of the first dose, 516 (52%) of 995 patients had restored catheter function.

One hundred twenty minutes after the instillation of the first dose, 747 (75%) of 995 patients had restored catheter function. If function was not restored after the first dose, a second dose was administered. Two hundred nine patients received a second dose.

Thirty minutes after instillation of the second dose, 70 (33%) of 209 patients had restored catheter function. One hundred twenty minutes after the instillation of the second dose, 97 (46%) of 209 patients had restored catheter function. A total of 844 (85%) of 995 patients had function restored after up to 2 doses.

Across Trials 1 and 2, 796 (68%) of 1043 patients with occlusions present for less than 14 days had restored function after one dose, and 902 (88%) had function restored after up to two doses. Of 53 patients with occlusions present for longer than 14 days, 30 (57%) patients had function restored after a single dose, and a total of 38 patients (72%) had restored function after up to two doses. Three hundred forty-six patients who had successful treatment outcome were evaluated at 30 days after treatment.

The incidence of recurrent catheter dysfunction within this period was 26%. Trial 3 was an open‑label, single‑arm trial in 310 patients between the ages of 2 weeks and 17 years. All patients had catheter dysfunc… [Excerpted — this section continues on DailyMed.]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 85 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long‑term studies in animals have not been performed to evaluate the carcinogenic potential or the effect on fertility. Short-term studies that evaluated tumorigenicity of Alteplase and effect on tumor metastases were negative in rodents. Studies to determine mutagenicity (Ames test) and chromosomal aberration assays in human lymphocytes were negative at all concentrations tested.

Cytotoxicity, as reflected by a decrease in mitotic index, was evidenced only after prolonged exposure at high concentrations exceeding those expected to be achieved with Cathflo Activase.

📚 References 152 words ▾

REFERENCES Collen D, Lijnen HR. Fibrinolysis and the control of hemostasis. In: Stamatoyannopoulos G, Nienhui AW, Majerus PW, Varmus H, editors.

The molecular basis of blood diseases, 2nd edition. Philadelphia: Saunders, 1994:662–88. Tanswell P, Tebbe U, Neuhaus K-L, Glasle-Schwarz L, Wojick J, Seifried E.

Pharmacokinetics and fibrin specificity of alteplase during accelerated infusions in acute myocardial infarction. J Am Coll Cardiol 1992;19:1071–5. Califf RM, Topol EJ, George BS, Boswick JM, Abbottsmith C, Sigmon KN, et al., and the Thrombolysis and Angioplasty in Myocardial Infarction Study Group.

Hemorrhagic complications associated with the use of intravenous tissue plasminogen activator in treatment of acute myocardial infarction. Am J Med 1988;85:353–9. Bovill EG, Terrin ML, Stump DC, Berke AD, Frederick M, Collen D, et al.

Hemorrhagic events during therapy with recombinant tissue-type plasminogen activator, heparin, and aspirin for acute myocardial infarction: results of the thrombolysis in myocardial infarction (TIMI), phase II trial. Ann Int Med 1991;115:256–65.

📄 Package Label / Principal Display Panel 42 words ▾

PRINCIPAL DISPLAY PANEL - 2 mg Vial Carton NDC 50242-041-64 US License No.: 1048 cathflo ® activase ® (ALTEPLASE) 2 mg For Use in Central Venous Access Devices Rx only KEEP REFRIGERATED 10165659 Genentech Principal Display Panel - 2 mg Vial Carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
528
Units reimbursed last 4 qtrs
713
Gross reimbursed last 4 qtrs
$112.3K
Avg / prescription
$212.63
Avg / unit
$157.57
Latest quarter Q1 2026
40Rx
Fee-for-service vs managed care ⓘ
92% MCO
Fee-for-service · 44 Rx Managed care · 484 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 101 units · 1.3 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 54 units · 0.3 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 200 units · 1.6 per 100k residents IL Indiana: no data reported IN Ohio: 92 units · 0.8 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 162 units · 1.7 per 100k residents NJ Massachusetts: no data reported MA California: 16 units · 0.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 14 units · 0.2 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 37 units · 0.5 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 37 units · 0.1 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.01.7
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Jersey 1.7 /100k
2 Illinois 1.6 /100k
3 Washington 1.3 /100k
4 Ohio 0.8 /100k
5 Arizona 0.5 /100k
6 New York 0.3 /100k
7 Maryland 0.2 /100k
8 Texas 0.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial50242-0041-64 28,258 Rx · $8,711,639
10 vials this page50242-0041-10 528 Rx · $112,266
Drug total (last 4 qtrs): 28,786 Rx · 43,274 units · $8,823,905 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 Cathflo Activase (this brand).

Top reported reactions

Gingival Bleeding1,001
Death692
Cerebral Haemorrhage608
Haemorrhage Intracranial437
Product Storage Error336
Angioedema319
Haemorrhagic Transformation Stroke317

Age at onset

Neonate10
Infant27
Child62
Adolescent48
Adult1,448
Elderly1,472

Reporter sex

10,478 reports
Male · 52%
Female · 42%
Unknown · 6%

Serious outcomes

Death2,147
Hospitalization2,134
Life-threatening1,001
Disabling195
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,538 0
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 ✓ Available
Inactive ingredients (structured) ✓ 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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: this package is listed as actively marketed, with no marketing end date reported by Genentech, Inc.. Listing status can change — 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 1 vial (50242-0041-64). 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?
Genentech, Inc. 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2997 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 50242-0040-62 · Genentech, 50242-0044-13 · Genentech, →
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.