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Activase Alteplase Kit — NDC 50242-0044-13 package photo
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Activase Alteplase Kit — NDC 50242-044-13 (Billing 50242-0044-13)

by Genentech, Inc. · 1 KIT in 1 CARTON * 50 mL in 1 VIAL, SINGLE-USE * 50 mL in 1 VIAL, SINGLE-USE

This is a package of Activase Alteplase Kit from Genentech, Inc., marketed since Nov 1987 and currently FDA-listed. It is this product's only package size.

NDC 50242-0044-13
🏷️ FDA NDC (as labeled) 50242-044-13 billing pads the product segment with a zero
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 50242-044-13 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50242 labeler · 044 product · 13 package
Package marketed since
Nov 13, 1987
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5024204413 4
Medicaid fills, this package
234 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50242-044-13
Product NDC 50242-044
11-digit billing NDC 50242004413
NCPDP billing unit EA — each (per item)
RxCUI 1804799, 1804802, 1804804, 1804806
Application # BLA103172
SPL Set ID c669f77c-fa48-478b-a14b-80b20a0139c2
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1987-11-13
Dosage form KIT
Biologic (Purple Book) 351(a)

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

GPI-14 85601010002110
GPI class Activase
GCN Seq No 006508
GCN 47140
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 ACTIVASE 50 MG VIAL
FDB brand name Activase
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 006508
  • GCN: 47140
  • GPI-14 (Medi-Span): 85601010002110
  • HICL (First Databank): 002803
  • AHFS class code: 20:12.20.00
  • RxCUI (RxNorm): 1804799
Why two NDCs? The FDA registers this code as 50242-044-13 — 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 → 50242-0044-13. 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 Enzymes class.

Drug family (ATC) Enzymes, Other ophthalmologicals
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 ACTIVASE 50 MG VIAL Ingredient Alteplase
📖 What it is MedlinePlus · NLM

Alteplase is used to dissolve blood clots that have formed in blood vessels. It is used to reduce the risk of death or heart problems in people having a heart attack and to treat patients with symptoms of a stroke or a clot in the lung(s). Alteplase is in a class of medications called thrombolytics. It works by helping the body to dissolve blood clots.

Read the full MedlinePlus article ↗

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $4,983.11 —
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)50242-044-13
11-digit billing NDC50242-0044-13
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 / pkg50 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 1 MG, so one package = 50 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 Marketing startMarketing endStatus
50242-0044-13 You're viewing this Main listing 1 KIT in 1 CARTON * 50 mL in 1 VIAL, SINGLE-USE * 50 mL in 1 VIAL, SINGLE-USE 1987-11-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Activasethis 50242-0044-13 Genentech, 1 kit — — FDA listed —
Activase 50242-0085-27 Genentech, 1 kit — — 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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

LabelerGenentech, Inc.
FDA applicationBLA103172 (BLA)
Labeler code50242
First marketedNov 1987
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 💊 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Activase is a tissue plasminogen activator (tPA) indicated for the treatment of: Acute Ischemic Stroke (AIS). ( 1.1 ) Acute Myocardial Infarction (AMI) to reduce mortality and incidence of heart failure. ( 1.2 ) Limitation of Use in AMI: the risk of stroke may be greater than the benefit in patients at low risk of death from cardiac causes. ( 1.2 ) Acute Massive Pulmonary Embolism (PE) for lysis. ( 1.3 )

1.1Acute Ischemic Stroke Activase is indicated for the treatment of acute ischemic stroke. Exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms prior to initiation of treatment [see Contraindications (4.1) ] . Initiate treatment as soon as possible but within 3 hours after symptom onset.

1.2Acute Myocardial Infarction Activase is indicated for use in acute myocardial infarction (AMI) for the reduction of mortality and reduction of the incidence of heart failure. Limitation of Use: The risk of stroke may outweigh the benefit produced by thrombolytic therapy in patients whose AMI puts them at low risk for death or heart failure.

1.3Pulmonary Embolism Activase is indicated for the lysis of acute massive pulmonary embolism, defined as: Acute pulmonary emboli obstructing blood flow to a lobe or multiple lung segments. Acute pulmonary emboli accompanied by unstable hemodynamics, e.g., failure to maintain blood pressure without supportive measures.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Acute Ischemic Stroke : The recommended dose is 0.9 mg/kg (not to exceed 90 mg total dose) infused intravenously over 60 minutes with 10% of the total dose administered as an initial bolus over 1 minute. ( 2.1 ) Acute Myocardial Infarction : The recommended total dose is based on patient weight, not to exceed 100 mg. ( 2.2 ) Acute Massive Pulmonary Embolism : The recommended dose is 100 mg administered by IV infusion over 2 hours.

( 2.3 ) Do not add other medications to infusions containing Activase. ( 2.5 )

2.1Acute Ischemic Stroke Administer Activase as soon as possible but within 3 hours after onset of symptoms. The recommended dose is 0.9 mg/kg (not to exceed 90 mg total dose), with 10% of the total dose administered as an initial intravenous bolus over 1 minute and the remainder infused over 60 minutes. During and following Activase administration for the treatment of acute ischemic stroke, frequently monitor and control blood pressure.

In patients without recent use of oral anticoagulants or heparin, Activase treatment can be initiated prior to the availability of coagulation study results. Discontinue Activase if the pretreatment International Normalized Ratio (INR) is greater than 1.7 or the activated partial thromboplastin time (aPTT) is elevated [see Contraindications (4.1) ] .

2.2Acute Myocardial Infarction Administer Activase as soon as possible after the onset of symptoms. The recommended total doses for acute myocardial infarction (AMI) is based on patient weight, not to exceed 100 mg, regardless of the selected administration regimen (accelerated or 3 hour, described below). There are two Activase dose regimens (accelerated and 3-hour) for use in the management of AMI; there are no controlled studies to compare clinical outcomes with these regimens [see Clinical Studies (14.2) ].

Accelerated Infusion The recommended accelerated infusion dose consists of an IV bolus [see Dosage and Administration (2.4 , 2.5) ] followed by an IV infusion as set forth in Table 1 . Table 1 Accelerated Infusion Weight-Based Doses for Patients with AMI Patient weight Intravenous Bolus First 30 min Next 60 min > 67 kg 15 mg 50 mg 35 mg ≤ 67 kg 15 mg 0.75 mg/kg 0.50 mg/kg The safety and efficacy of accelerated infusion of Activase have only been investigated with concomitant administration of heparin and aspirin [see Clinical Studies (14.2) ] .

3-Hour Infusion For patients weighing ≥ 65 kg, the recommended dose is 100 mg administered as 60 mg in the first hour (6-10 mg administered as a bolus), 20 mg over the second hour, and 20 mg over the third hour. For smaller patients (< 65 kg), a dose of 1.25 mg/kg administered over 3 hours may be used. Weight-based doses are shown in Table 2 .

Table 2 3-hour Infusion Weight-Based Doses for Patients with AMI Patient weight Bolus Rest of 1st hour 2nd hour 3rd hour ≥ 65 kg 6-10 mg 50-54 mg 20 mg 20 mg < 65 kg 0.075 mg/kg 0.675 mg/kg 0.25 mg/kg 0.25 mg/kg

2.3Pulmonary Embolism (PE) The recommended dose is 100 mg administered by IV infusion over 2 hours. Institute parenteral anticoagulation near the end of or immediately following the Activase infusion when the partial thromboplastin time or thrombin time returns to twice normal or less.

2.4Activase 50 mg Reconstitution and Administration Instructions Activase is for intravenous administration only. Do not add any other medication to infusion solutions containing Activase. Extravasation of Activase infusion can cause ecchymosis or inflammation.

If extravasation occurs, terminate the infusion at that intravenous site and apply local therapy. Use within 8 hours following reconstitution (when stored at 2–30°C). Activase contains no antibacterial preservatives.

Activase 50 mg Reconstitution Notes Use only the accompanying Sterile Water for Injection (SWFI), USP without preservatives. Do not use Bacteriostatic Water for Injection, USP. Reconstitute using aseptic technique.

Slight foaming is not unusual; let stand undisturbed… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 54 words ▾

3 DOSAGE FORMS AND STRENGTHS 50 mg lyophilized powder in single-dose vial with 50 mL SWFI USP for reconstitution 100 mg lyophilized powder in single-dose vial with 100 mL SWFI USP for reconstitution 50 mg and 100 mg lyophilized powder in single-dose vials with Sterile Water for Injection USP for reconstitution. ( 3 )

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS General Active internal bleeding. ( 4.1 , 4.2 ) Recent intracranial or intraspinal surgery or serious head trauma. ( 4.1 , 4.2 ) Intracranial conditions that may increase the risk of bleeding.

( 4.1 , 4.2 ) Bleeding diathesis. ( 4.1 , 4.2 ) Current severe uncontrolled hypertension. ( 4.1 , 4.2 ) Acute Ischemic Stroke Current intracranial hemorrhage.

( 4.1 ) Subarachnoid hemorrhage. ( 4.1 ) Acute Myocardial Infarction or Pulmonary Embolism History of recent stroke. ( 4.2 )

4.1Acute Ischemic Stroke Do not administer Activase to treat acute ischemic stroke in the following situations in which the risk of bleeding is greater than the potential benefit [see Warnings and Precautions (5.1) ] : Current intracranial hemorrhage Subarachnoid hemorrhage Active internal bleeding Recent (within 3 months) intracranial or intraspinal surgery or serious head trauma Presence of intracranial conditions that may increase the risk of bleeding (e.g., some neoplasms, arteriovenous malformations, or aneurysms) Bleeding diathesis Current severe uncontrolled hypertension.

4.2Acute Myocardial Infarction or Pulmonary Embolism Do not administer Activase for treatment of AMI or PE in the following situations in which the risk of bleeding is greater than the potential benefit [see Warnings and Precautions (5.1) ]: Active internal bleeding History of recent stroke Recent (within 3 months) intracranial or intraspinal surgery or serious head trauma Presence of intracranial conditions that may increase the risk of bleeding (e.g. some neoplasms, arteriovenous malformations, or aneurysms) Bleeding diathesis Current severe uncontrolled hypertension.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Increases the risk of bleeding. Avoid intramuscular injections. Monitor for bleeding.

If serious bleeding occurs, discontinue Activase. ( 5.1 ) Monitor patients during and for several hours after infusion for hypersensitivity. If signs of hypersensitivity develop, discontinue Activase.

( 5.2 ) Consider the risk of reembolization from the lysis of underlying deep venous thrombi in patients with pulmonary embolism. ( 5.3 ) Cholesterol embolism has been reported rarely in patients treated with thrombolytic agents. ( 5.4 )

5.1Bleeding Activase can cause significant, sometimes fatal, internal or external bleeding, especially at arterial and venous puncture sites. Avoid intramuscular injections and trauma to the patient while on Activase. Perform venipunctures carefully and only as required.

To minimize bleeding from noncompressible sites, avoid internal jugular and subclavian venous punctures. If an arterial puncture is necessary during Activase infusion, use an upper extremity vessel that is accessible to manual compression, apply pressure for at least 30 minutes, and monitor the puncture site closely. Because of the higher risk of intracranial hemorrhage in patients treated for acute ischemic stroke, limit treatment to facilities that can provide timely access to appropriate evaluation and management of intracranial hemorrhage.

Fatal cases of hemorrhage associated with traumatic intubation in patients administered Activase have been reported. Aspirin and heparin have been administered concomitantly with and following infusions of Activase in the management of acute myocardial infarction and pulmonary embolism, but the concomitant administration of heparin and aspirin with and following infusions of Activase for the treatment of acute ischemic stroke during the first 24 hours after symptom onset has not been investigated. Because heparin, aspirin, or Activase may cause bleeding complications, carefully monitor for bleeding, especially at arterial puncture sites.

Hemorrhage can occur 1 or more days after administration of Activase, while patients are still receiving anticoagulant therapy. If serious bleeding occurs, terminate the Activase infusion and treat appropriately. In the following conditions, the risks of bleeding with Activase therapy for all approved indications are increased and should be weighed against the anticipated benefits: Recent major surgery or procedure, (e.g., coronary artery bypass graft, obstetrical delivery, organ biopsy, previous puncture of noncompressible vessels) Cerebrovascular disease Recent intracranial hemorrhage Recent gastrointestinal or genitourinary bleeding Recent trauma Hypertension: systolic BP above 175 mm Hg or diastolic BP above 110 mm Hg Acute pericarditis Subacute bacterial endocarditis Hemostatic defects including those secondary to severe hepatic or renal disease Significant hepatic dysfunction Pregnancy Diabetic hemorrhagic retinopathy, or other hemorrhagic ophthalmic conditions Septic thrombophlebitis or occluded AV cannula at seriously infected site Advanced age [see Use in Specific Populations (8.5) ] Patients currently receiving anticoagulants (e.g., warfarin sodium) Any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location.

5.2Hypersensitivity Hypersensitivity, including urticarial / anaphylactic reactions, have been reported after administration of Activase (e.g., laryngeal edema, rash and shock). Rare fatal outcome for hypersensitivity was reported. Angioedema has been observed during and up to 2 hours after Activase infusion in patients treated for acute ischemic stroke and acute myocardial infarction.

In many cases, patients received concomitant angiotensin-converting enzyme inhibitors [see Drug Interactions (7) ] . Monitor patients treated with Activase during and for several hours after infusion for hypersensitivity. If signs of hypersensitivity occur, e.g. anaphyl… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in the other sections of the label: Bleeding [see Contraindications (4) , Warnings and Precautions (5.1) ] Hypersensitivity [see Warnings and Precautions (5.2) ] Thromboembolism [see Warnings and Precautions (5.3) ] Cholesterol Embolization [see Warnings and Precautions (5.4) ] The most frequently occurring adverse reaction ( > 5%) is bleeding. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 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 frequent adverse reaction associated with Activase in all approved indications is bleeding. Bleeding Acute Ischemic Stroke (AIS) In clinical studies in patients with AIS (Studies 1 and 2) the incidence of intracranial hemorrhage, especially symptomatic intracranial hemorrhage, was higher in Activase-treated patients than in placebo patients.

A dose-finding study of Activase suggested that doses greater than 0.9 mg/kg may be associated with an increased incidence of intracranial hemorrhage. The incidence of all-cause 90-day mortality, intracranial hemorrhage, and new ischemic stroke following Activase treatment compared to placebo are presented in Table 3 as a combined safety analysis (n=624) for Studies 1 and 2. These data indicate a significant increase in intracranial hemorrhage following Activase treatment, particularly symptomatic intracranial hemorrhage within 36 hours.

There was no increase in the incidences of 90-day mortality or severe disability in Activase-treated patients compared to placebo. Table 3 Combined Safety Outcomes for Studies 1 and 2 Placebo (n= 312) Activase (n=312) p-Value Fisher's Exact Test. All-Cause 90-day Mortality 64 (20.5%) 54 (17.3%)

0.36Total ICH Within trial follow-up period. Symptomatic intracranial hemorrhage was defined as the occurrence of sudden clinical worsening followed by subsequent verification of intracranial hemorrhage on CT scan. Asymptomatic intracranial hemorrhage was defined as intracranial hemorrhage detected on a routine repeat CT scan without preceding clinical worsening.

20 (6.4%) 48 (15.4%) <0.01 Symptomatic 4 (1.3%) 25 (8.0%) <0.01 Asymptomatic 16 (5.1%) 23 (7.4%)

0.32Symptomatic Intracranial Hemorrhage within 36 hours 2 (0.6%) 20 (6.4%) <0.01 New Ischemic Stroke (3-months) 17 (5.4%) 18 (5.8%)

1.00Bleeding events other than intracranial hemorrhage were noted in the studies of AIS and were consistent with the general safety profile of Activase. In Studies 1 and 2, the frequency of bleeding requiring red blood cell transfusions was 6.4% for Activase-treated patients compared to 3.8% for placebo (p = 0.19). Although exploratory analyses of Studies 1 and 2 suggest that severe neurological deficit (National Institutes of Health Stroke Scale [NIHSS > 22]) at presentation was associated with an increased risk of intracranial hemorrhage, efficacy results suggest a reduced but still favorable clinical outcome for these patients.

Acute Myocardial Infarction (AMI) For the 3-hour infusion regimen in the treatment of AMI, the incidence of significant internal bleeding (estimated as > 250 mL blood loss) has been reported in studies in over 800 patients ( Table 4 ). These data do not include patients treated with the Activase accelerated infusion. Table 4 Incidence of Bleeding in 3-Hour Infusion in AMI Patients Total Dose ≤100 mg Gastrointestinal 5% Genitourinary 4% Ecchymosis 1% Retroperitoneal <1% Epistaxis <1% Gingival <1% The incidence of intracranial hemorrhage in AMI patients treated with Activase is presented in Table 5 .

Table 5 Incidence of Intracranial Hemorrhage in AMI Patients Dose Number of Patients Intracranial… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 95 words ▾

7 DRUG INTERACTIONS The interaction of Activase with other cardioactive or cerebroactive drugs has not been studied. Anticoagulants and antiplatelet drugs increase the risk of bleeding if administered prior to, during, or after Activase therapy. In the post-marketing setting, there have been reports of angioedema in patients (primarily patients with AIS) receiving concomitant angiotensin-converting enzyme inhibitors. [see Warnings and Precautions (5.2) ].

Anticoagulants and drugs that inhibit platelet function increase the risk of bleeding when administered with Activase therapy. ( 7 ) Concomitant angiotensin-converting enzyme inhibitors may increase the risk of angioedema. ( 7 )

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Published studies and case reports on alteplase use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. Alteplase is embryocidal in rabbits when intravenously administered during organogenesis at the clinical exposure for AMI, but no maternal or fetal toxicity was evident at lower exposure in pregnant rats or rabbits (see Data ) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Maternal Adverse Reactions The most common complication of thrombolytic therapy is bleeding.

Pregnancy may increase this risk [see Warnings and Precautions (5.1) ]. Data Animal Data Alteplase is embryocidal in rabbits when administered intravenously during organogenesis in doses (3 mg/kg) approximately equal to the human exposure (based on AUC) at the dose for AMI. No maternal or fetal toxicity was evident at doses (1 mg/kg) approximately 0.3 times the human exposure.

In pregnant rats, no maternal or fetal toxicity was evident at doses (1 mg/kg) approximately 0.6 times the human dose for AMI (based on body weight) dosed during the period of organogenesis.

8.2Lactation Risk Summary There are no data on the presence of alteplase in human milk, the effects on the breastfed infant, or the effects on milk production.

8.4Pediatric Use Safety and effectiveness of Activase in pediatric patients have not been established.

8.5Geriatric Use Acute Ischemic Stroke In exploratory, multivariate analyses of Studies 1 and 2, age greater than 77 years was one of several interrelated baseline characteristics associated with an increased risk of intracranial hemorrhage. Efficacy results suggest a reduced but still favorable clinical outcome for Activase-treated elderly [see Clinical Studies (14.1) ] . Acute Myocardial Infarction In a large trial of accelerated-infusion Activase that enrolled 41,021 patients with AMI to one of four thrombolytic regimens [see Clinical Studies (14.2) ] , patients over 75 years of age, a predefined subgroup, comprised 12% of enrollment.

In these patients, the incidence of stroke was 4.0% for the Activase accelerated infusion group, 2.8% for streptokinase IV [SK (IV)], and 3.2% for streptokinase SQ [SK (SQ)]. The incidence of combined 30-day mortality or nonfatal stroke was 20.6% for accelerated infusion of Activase, 21.5% for SK (IV), and 22.0% for SK (SQ).

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Published studies and case reports on alteplase use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. Alteplase is embryocidal in rabbits when intravenously administered during organogenesis at the clinical exposure for AMI, but no maternal or fetal toxicity was evident at lower exposure in pregnant rats or rabbits (see Data ) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Maternal Adverse Reactions The most common complication of thrombolytic therapy is bleeding.

Pregnancy may increase this risk [see Warnings and Precautions (5.1) ]. Data Animal Data Alteplase is embryocidal in rabbits when administered intravenously during organogenesis in doses (3 mg/kg) approximately equal to the human exposure (based on AUC) at the dose for AMI. No maternal or fetal toxicity was evident at doses (1 mg/kg) approximately 0.3 times the human exposure.

In pregnant rats, no maternal or fetal toxicity was evident at doses (1 mg/kg) approximately 0.6 times the human dose for AMI (based on body weight) dosed during the period of organogenesis.

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and effectiveness of Activase in pediatric patients have not been established.

🧓 Geriatric Use 148 words ▾

8.5Geriatric Use Acute Ischemic Stroke In exploratory, multivariate analyses of Studies 1 and 2, age greater than 77 years was one of several interrelated baseline characteristics associated with an increased risk of intracranial hemorrhage. Efficacy results suggest a reduced but still favorable clinical outcome for Activase-treated elderly [see Clinical Studies (14.1) ] . Acute Myocardial Infarction In a large trial of accelerated-infusion Activase that enrolled 41,021 patients with AMI to one of four thrombolytic regimens [see Clinical Studies (14.2) ] , patients over 75 years of age, a predefined subgroup, comprised 12% of enrollment.

In these patients, the incidence of stroke was 4.0% for the Activase accelerated infusion group, 2.8% for streptokinase IV [SK (IV)], and 3.2% for streptokinase SQ [SK (SQ)]. The incidence of combined 30-day mortality or nonfatal stroke was 20.6% for accelerated infusion of Activase, 21.5% for SK (IV), and 22.0% for SK (SQ).

🧬 Clinical Pharmacology 168 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Alteplase is a serine protease responsible for fibrin-enhanced conversion of plasminogen to plasmin. It produces limited conversion of plasminogen in the absence of fibrin. When introduced into the systemic circulation at pharmacologic concentration, alteplase binds to fibrin in a thrombus and converts the entrapped plasminogen to plasmin. This initiates local fibrinolysis with limited systemic proteolysis.

12.2Pharmacodynamics Following administration of 100 mg Activase, there is a decrease (16%-36%) in circulating fibrinogen. In a controlled trial, 8 of 73 patients (11%) receiving Activase (1.25 mg/kg body weight over 3 hours) experienced a decrease in fibrinogen to below 100 mg/dL.

12.3Pharmacokinetics Alteplase in acute myocardial infarction (AMI) patients is rapidly cleared from the plasma with an initial half-life of less than 5 minutes. There is no difference in the dominant initial plasma half-life between the 3-hour and accelerated regimens for AMI. The plasma clearance of alteplase is 380-570 mL/min, primarily mediated by the liver. The initial volume of distribution approximates plasma volume.

🧬 Mechanism of Action 59 words ▾

12.1Mechanism of Action Alteplase is a serine protease responsible for fibrin-enhanced conversion of plasminogen to plasmin. It produces limited conversion of plasminogen in the absence of fibrin. When introduced into the systemic circulation at pharmacologic concentration, alteplase binds to fibrin in a thrombus and converts the entrapped plasminogen to plasmin. This initiates local fibrinolysis with limited systemic proteolysis.

📦 How Supplied / Storage and Handling 152 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Activase is supplied as a sterile, lyophilized powder in 50 mg single-dose vials containing vacuum and in 100 mg single-dose vials without vacuum. Each 50 mg Activase vial (29 million IU) is packaged with diluent for reconstitution (50 mL Sterile Water for Injection, USP): NDC 50242-044-13. Each 100 mg Activase vial (58 million IU) is packaged with diluent for reconstitution (100 mL Sterile Water for Injection, USP), and one transfer device: NDC 50242-085-27.

16.2Stability and Storage Store lyophilized Activase at controlled room temperature not to exceed 30°C (86°F), or under refrigeration at 2° to 8°C (36° to 46°F). Protect the lyophilized material during extended storage from excessive exposure to light. If stored between 2-30°C (36-86°F), Activase may be used within 8 hours following reconstitution.

Discard any unused solution after administration is complete. Do not use beyond the expiration date stamped on the vial.

📦 Storage and Handling 71 words ▾

16.2Stability and Storage Store lyophilized Activase at controlled room temperature not to exceed 30°C (86°F), or under refrigeration at 2° to 8°C (36° to 46°F). Protect the lyophilized material during extended storage from excessive exposure to light. If stored between 2-30°C (36-86°F), Activase may be used within 8 hours following reconstitution.

Discard any unused solution after administration is complete. Do not use beyond the expiration date stamped on the vial.

📋 Description 157 words ▾

11 DESCRIPTION Alteplase is a tissue plasminogen activator 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 obtained from a human melanoma cell line.

Biological potency is determined by an in vitro clot lysis assay and is expressed in International Units (IU). Activase (alteplase) is a sterile, white to off-white, lyophilized powder for intravenous administration after reconstitution with Sterile Water for Injection, USP. Table 6 Quantitative Composition of the Lyophilized Product 100 mg Vial 50 mg Vial Alteplase 100 mg (58 million IU) 50 mg (29 million IU) L-Arginine 3.5 g 1.7 g Phosphoric Acid 1 g 0.5 g Polysorbate 80 10 mg 5 mg Vacuum No Yes The reconstituted preparation results in a colorless to pale yellow transparent solution containing Activase 1 mg/mL at approximately pH 7.3.

The osmolality of this solution is approximately 215 mOsm/kg.

💬 Information for Patients 62 words ▾

17 PATIENT COUNSELING INFORMATION Following Activase administration, patients are at increased risk of bleeding internally or externally. Advise patients to contact a health-care professional if they experience symptoms or signs consistent with bleeding (e.g., unusual bruising, pink or brown urine, red or black or tarry stools, coughing up blood, vomiting blood or blood that looks like coffee grounds), headache, or stroke symptoms.

🧬 Pharmacokinetics 63 words ▾

12.3Pharmacokinetics Alteplase in acute myocardial infarction (AMI) patients is rapidly cleared from the plasma with an initial half-life of less than 5 minutes. There is no difference in the dominant initial plasma half-life between the 3-hour and accelerated regimens for AMI. The plasma clearance of alteplase is 380-570 mL/min, primarily mediated by the liver. The initial volume of distribution approximates plasma volume.

🧬 Pharmacodynamics 43 words ▾

12.2Pharmacodynamics Following administration of 100 mg Activase, there is a decrease (16%-36%) in circulating fibrinogen. In a controlled trial, 8 of 73 patients (11%) receiving Activase (1.25 mg/kg body weight over 3 hours) experienced a decrease in fibrinogen to below 100 mg/dL.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Acute Ischemic Stroke (AIS) Two placebo-controlled, double-blind trials (Studies 1 and 2) were conducted in patients with AIS. Both studies enrolled patients with measurable neurological deficit who could complete screening and begin study treatment within 3 hours from symptom onset. A cranial computerized tomography (CT) scan was performed prior to treatment to rule out the presence of intracranial hemorrhage.

Blood pressure was actively controlled (185/110 mm Hg or lower) for 24 hours. Patients were randomized (1:1) to receive either 0.9 mg/kg Activase (maximum of 90 mg) or placebo. Activase was administered as a 10% initial IV bolus over 1 minute followed by continuous IV infusion of the remainder over 60 minutes.

Study treatment was initiated prior to the availability of coagulation study results in patients without recent use of oral anticoagulants and/or heparin and was discontinued if the pretreatment prothrombin time (PT) was greater than 15 seconds or the activated partial thromboplastin time (aPTT) was elevated. Patients with prior aspirin use were included. Administration of anticoagulants and antiplatelet agents was prohibited for the first 24 hours following symptom onset.

Study 1 (n=291) evaluated neurological improvement at 24 hours after stroke onset. The primary endpoint, the proportion of patients with a 4 point or greater improvement in the National Institutes of Health Stroke Scale (NIHSS) score or complete recovery (NIHSS score of 0), was not significantly different between treatment groups. A prespecified secondary analysis suggested improved 3-month outcome associated with Activase treatment using the following stroke assessment scales: Barthel Index, Modified Rankin Scale, Glasgow Outcome Scale, and the NIHSS.

Study 2 (n=333) assessed clinical outcome at 3 months. A favorable outcome was defined as minimal or no disability using four stroke assessment scales: Barthel Index (score of 95 or greater), Modified Rankin Scale (score of 1 or less), Glasgow Outcome Scale (score of 1), and NIHSS (score of 1 or less). The results comparing Activase- and placebo-treated patients for the four outcome scales together (Generalized Estimating Equations) and individually are presented in Table 7 .

In this study, depending upon the scale, the favorable outcome of minimal or no disability occurred in at least 11 per 100 more patients treated with Activase than those receiving placebo. Study results demonstrated consistent functional and neurological improvement within all four stroke scales as indicated by median scores. These results were consistent with the 3-month outcome treatment effects observed in Study 1.

Table 7 Study 2 Three-Month Efficacy Outcomes Analysis Frequency of Favorable Outcome Favorable Outcome is defined as recovery with minimal or no disability. Placebo (n=165) Activase (n=168) Absolute Difference (95% CI) Odds Ratio Value greater than 1 indicates odds of recovery in favor of Activase treatment. (95% Cl) p-Value p-Value for Odds Ratio is from Generalized Estimating Equations with logit link.

Generalized Estimating Equations (Multivariate) - - - 1.71 (1.15, 2.56)

0.02Barthel Index 37.6% 50.0% 12.4% (3.0, 21.9) 1.66 (1.07, 2.57)

0.02Modified Rankin Scale 26.1% 38.7% 12.6% (3.7, 21.6) 1.79 (1.12, 2.85)

0.02Glasgow Outcome Scale 31.5% 44.0% 12.5% (3.3, 21.8) 1.71 (1.09, 2.68)

0.02NIHSS 20.0% 31.0% 11.0% (2.6, 19.3) 1.79 (1.06, 2.96)

0.02In a prespecified subgroup analysis of patients receiving aspirin prior to onset of stroke symptoms, the favorable outcome for Activase-treated patients was preserved.

14.2Acute Myocardial Infarction (AMI) Two Activase dose regimens have been studied in patients experiencing acute myocardial infarction [see Dosage and Administration (2.2) ]. The comparative efficacy of these two regimens has not been evaluated. Accelerated Infusion in AMI Patients Accelerated infusion of Activase was studied in an international, multi-center trial that ran… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 84 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, 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, which evaluated tumorigenicity of Activase and effect on tumor metastases in rodents, were negative. 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 and only at the highest concentrations tested.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 81 words ▾

13.1Carcinogenesis, 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, which evaluated tumorigenicity of Activase and effect on tumor metastases in rodents, were negative. 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 and only at the highest concentrations tested.

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE Activase® (alteplase) for injection for intravenous use 100 mg (58 million IU) Read before preparing Activase® See also enclosed, full prescribing information Instructions for Use should accompany reconstituted Activase to patient bedside. Kit Contents Transfer device Activase vial (no vacuum) Activase vial stopper parts: Sterile Water for Injection (water) vial Note: Do not use Bacteriostatic Water for Injection, USP. Prescribing Information Instructions for Use Also Required (not included in kit) 1 Luer syringe for removing bolus dose, as needed 1 Luer syringe for removing excess volume, as needed 2 large bore needles 2 Alcohol swabs IV infusion set Reconstitution (use aseptic technique) Step 1: Cleaning Step 2: Spiking Water vial Step 3: Spiking Activase vial Remove caps from both vials.

Wipe each stopper with a separate alcohol swab. Remove cover from one end of transfer device . Do not wipe transfer device spikes with alcohol.

(Note: Either side of transfer device can be used). Insert spike straight through center of water vial stopper. Do not invert water vial yet.

Inverting too early may lead to leakage and incorrect dosing. Remove cover from other end of transfer device. Hold Activase vial upside down over spike.

Press Activase vial down to insert spike straight through center of Activase vial stopper. Inserting the spike off-center could lead to stopper collapse. Reconstitution (use aseptic technique) Administration Warning Step 4: Inverting and transferring Step 5: Inspecting Invert vials so that water vial is on top.

Allow all water to transfer into Activase vial. If the flow does not start immediately or pauses, initiate the flow by flipping and re-inverting the vials. Swirl gently and/or invert slowly to dissolve Activase powder.

Do not shake vials. Shaking may lead to excessive foaming and degraded medication. Separate empty water vial and transfer device from Activase vial.

Reconstituted Activase vial (1 mg/mL) should be: Colorless to pale yellow and transparent Free of particulates If needed, let stand undisturbed for a few minutes to allow large bubbles to dissipate. Review important information below before continuing to Step 6. Do not push air from the syringe into the vial.

The vial is not under vacuum and adding air at any time may result in leakage and incorrect dosing. Only insert needles within center ring of stopper, away from hole made by transfer device. Insert needle within center ring of stopper, away from the hole made by transfer device when withdrawing medication to avoid leakage and incorrect dosing.

Do not insert needles outside of the center ring of stopper. Administration (use aseptic technique) Step 6: Preparing bolus Step 7: Removing excess volume Step 8: Spiking and hanging Check if bolus is needed. If yes, attach needle to empty Luer syringe.

Insert needle once through center ring of stopper, away from hole made by transfer device, and slowly withdraw the bolus amount. Check if there is excess volume in vial. If yes, attach needle to empty Luer syringe.

Insert needle once through center ring of stopper, away from hole made by transfer device, and slowly withdraw the excess volume. Insert spike from IV tubing set into center of vial stopper, through same hole made by transfer device. Do not push any air from syringe into vial (may cause leakage).

Do not push any air from syringe into vial (may cause leakage). Do not make a new hole in the vial stopper. Additional holes in vial stopper may lead to leakage.

Alternatively, the bolus can be left in the vial and administered via an infusion pump or removed from a port on the infusion line. Discard any excess volume. Leave infusion dose in vial.

Peel clear plastic hanger from vial label. Hang on IV pole and administer per facility protocol. Administration Notes Activase is for intravenous administration only.

Do not add any other medication to infusion solutions containing Activase. Extravasation of Activase infusion can ca… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 7 words ▾

Dosage and Administration ( 2.5 ) 09/2022

📄 Package Label / Principal Display Panel 86 words ▾

PRINCIPAL DISPLAY PANEL - Kit Carton - 50 mg NDC 50242-044-13 Activase ® (alteplase) For Injection 50 mg per vial For Intravenous Use Single-Dose Vial Discard Unused Portion a tissue plasminogen activator 10243242 Genentech PRINCIPAL DISPLAY PANEL - Kit Carton - 50 mg

PRINCIPAL DISPLAY PANEL - Kit Carton - 100 mg NDC 50242-085-27 Activase ® (alteplase) For Injection 100 mg per vial For Intravenous Use Single-Dose Vial Discard Unused Portion a tissue plasminogen activator 10236862 Genentech PRINCIPAL DISPLAY PANEL - Kit Carton - 100 mg

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
234
Units reimbursed last 4 qtrs
17
Gross reimbursed last 4 qtrs
$84.7K
Avg / prescription
$362.02
Avg / unit
$4,913.74
Latest quarter Q1 2026
37Rx
Fee-for-service vs managed care ⓘ
16% FFS 84% MCO
Fee-for-service · 37 Rx Managed care · 197 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: 2 units · 0.1 per 100k residents 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: 2 units · 0.0 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: no data reported IL Indiana: 2 units · 0.0 per 100k residents IN Ohio: 4 units · 0.0 per 100k residents OH Pennsylvania: 2 units · 0.0 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported 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: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported 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: 6 units · 0.6 per 100k residents 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: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.00.6
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 Delaware 0.6 /100k
2 Idaho 0.1 /100k
3 Ohio 0.0 /100k
4 Indiana 0.0 /100k
5 Pennsylvania 0.0 /100k
6 New York 0.0 /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.

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 Activase (this brand).

Top reported reactions

Death1,094
Gingival Bleeding1,029
Cerebral Haemorrhage819
Haemorrhage Intracranial734
Angioedema621
Haemorrhage563
Haemorrhagic Transformation Stroke431

Reporter sex

12,777 reports
Male · 53%
Female · 43%
Unknown · 5%

Serious outcomes

Death3,072
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,148 231
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 Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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) — 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 — 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.
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.
← 50242-0041-10 · Genentech, 50242-0051-10 · 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.