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Humate-P antihemophilic factor/von willebrand factor complex (human) Kit — NDC 63833-0616-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Humate-P antihemophilic factor/von willebrand factor complex (human) Kit — NDC 63833-616-02 (Billing 63833-0616-02)

by CSL Behring GmbH · 1 KIT in 1 CARTON * 10 mL in 1 VIAL * 10 mL in 1 VIAL, SINGLE-DOSE

This is a package of Humate-P antihemophilic factor/von willebrand factor complex (human) Kit from CSL Behring GmbH, marketed since May 1986 and currently FDA-listed. It is this product's only package size.

NDC 63833-0616-02
🏷️ FDA NDC (as labeled) 63833-616-02 billing pads the product segment with a zero
Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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NDC database record

One package, one record: these facts belong to NDC 63833-616-02 alone.

Record
FDA NDC Directory package listing · Plasma derivative
Code segments
63833 labeler · 616 product · 02 package
Package marketed since
May 1, 1986
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6383361602 3
Medicaid fills, this package
369 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63833-616-02
Product NDC 63833-616
11-digit billing NDC 63833061602
NCPDP billing unit EA — each (per item)
Application # BLA103960
SPL Set ID c5f4b63b-8d8b-45b3-b530-2f1c32a1b852
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1986-05-01
Dosage form KIT
Biologic (Purple Book) 351(a)

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

GPI-14 85100015102132
GPI class Humate-P
GCN Seq No 060325
GCN 26451
HICL code 017395
Ingredient (HICL) Antihemophilic Factor/Vwf
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M0
Therapeutic class — intermediate (HIC2) Blood And Blood Replacement Preparations
HIC3 code M0E
Therapeutic class — specific (HIC3) Antihemophilic Factors
AHFS code 20:28.16.00
AHFS class Hemostatics
FDB label name HUMATE-P 1,200 UNIT VWF:RCO
FDB brand name Humate-P
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 060325
  • GCN: 26451
  • GPI-14 (Medi-Span): 85100015102132
  • HICL (First Databank): 017395
  • AHFS class code: 20:28.16.00
Why two NDCs? The FDA registers this code as 63833-616-02 — 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 → 63833-0616-02. 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 HUMATE-P 1,200 UNIT VWF:RCO Ingredient Antihemophilic Factor/Vwf

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 $1.24 —
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J7187 $1.535 / J7187 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)63833-616-02
11-digit billing NDC63833-0616-02
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ7187
DescriptorInjection, von willebrand factor complex (humate-p), per iu vwf:rco
Billing units / pkg1 units
How the units are derivedThis package is 1; the HCPCS unit is 1 IU, so one package = 1 billing unit.
Medicare Part B spend (2026 (Q1))$7,445,810 · 315 claims · $23,637.49 per claim (all NDCs under J7187)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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
63833-0616-02 You're viewing this Main listing 1 KIT in 1 CARTON * 10 mL in 1 VIAL * 10 mL in 1 VIAL, SINGLE-DOSE 1986-05-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Humate-P 63833-0615-02 CSL 1 kit — — FDA listed —
Humate-Pthis 63833-0616-02 CSL 1 kit — — FDA listed —
Humate-P 63833-0617-02 CSL 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

🏛️
2000
First FDA approval
Apr 2000
📍
2026
Currently FDA-listed
26 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
AlphanateAntihemophilic Factor/von Willebrand Factor Complex (Human) Humate-PAntihemophilic Factor/von Willebrand Factor Complex (Human)
🔒 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

LabelerCSL Behring GmbH
FDA applicationBLA103960 (BLA)
Labeler code63833
First marketedMay 1986
Product typePlasma Derivative
Portfolio11 products on file

More NDCs from CSL Behring GmbH labeler code 63833

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 FDA label FDA SPL

The complete FDA label for this product, 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 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Humate-P is an Antihemophilic Factor/von Willebrand Factor (VWF) Complex (Human) indicated for: Hemophilia A – Treatment and prevention of bleeding in adults ( 1.1 ). Von Willebrand disease (VWD) – in adults and pediatric patients in the (1) Treatment of spontaneous and trauma-induced bleeding episodes, and (2) Prevention of excessive bleeding during and after surgery. This applies to patients with severe VWD as well as patients with mild to moderate VWD where the use of desmospressin is known or suspected to be inadequate ( 1.2 ).

Humate-P is not indicated for the prophylaxis of spontaneous bleeding episodes in VWD.

1.1Hemophilia A Humate-P, Antihemophilic Factor/von Willebrand Factor Complex (Human), is indicated for treatment and prevention of bleeding in adults with hemophilia A (classical hemophilia).

1.2Von Willebrand Disease (VWD) Humate-P is also indicated in adult and pediatric patients with von Willebrand disease (VWD) for: (1) treatment of spontaneous and trauma-induced bleeding episodes, and (2) prevention of excessive bleeding during and after surgery. This applies to patients with severe VWD as well as patients with mild to moderate VWD where use of desmopressin (DDAVP) is known or suspected to be inadequate. Controlled clinical trials to evaluate the safety and efficacy of prophylactic dosing with Humate-P to prevent spontaneous bleeding have not been conducted in VWD subjects (see Clinical Studies [14] ) .

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For intravenous use only. Hemophilia A One IU of factor VIII (FVIII) activity per kg body weight increases the circulating FVIII level by approximately

2.0IU/dL. Individualize dosage based on the patient's weight, type and severity of hemorrhage, FVIII level, and presence of inhibitors (see Table 1 for dosing recommendations) ( 2.1 ). VWD Treatment of bleeding episodes – Administer 40-80 IU VWF:Ristocetin Cofactor (RCo) per kg body weight every 8-12 hours ( 2.2 ).

Prevention of excessive bleeding during and after surgery for all types of VWD ( 2.3 ). Type of Surgery (see Table 3 for complete surgical dosing) Calculation of Loading Dose Initial maintenance dose should be half the loading dose (see Table 4 for monitoring recommendations). IU = International Units.

BW = body weight. Major Surgery ( 2.3 ) Δ Δ = Target peak plasma VWF:RCo level – baseline plasma VWF:RCo level. VWF:RCo × BW (kg) IVR IVR = in vivo recovery as measured in the patient.

If the IVR is unknown, use

2.0IU/dL per IU/kg. = IU VWF:RCo required Minor/Oral Surgery Oral surgery is defined as extraction of fewer than three teeth, if the teeth are non-molars and have no bony involvement. ( 2.3 ) Δ VWF:RCo × BW (kg) IVR = IU VWF:RCo required Emergency Surgery ( 2.3 ) Administer a dose of 50-60 IU VWF:RCo/kg BW

2.1Therapy for Hemophilia A One IU of Factor VIII (FVIII) activity per kg body weight will increase the circulating FVIII level by approximately

2.0International Units (IU)/dL. Dosage must be individualized based on the patient's weight, type and severity of hemorrhage, FVIII level, and presence of inhibitors. Judge the adequacy of treatment by clinical effects and, in all cases, adjust doses as needed based on clinical judgment and on frequent monitoring of the patient's FVIII level.

Table 1 provides dosing recommendations for the treatment of hemophilia A in adults. Table 1: Dosing Recommendations for the Treatment of Hemophilia A in Adults 1 Hemorrhagic Event Dosage (IU FVIII:C/kg Body Weight) IU = International Units. Minor hemorrhage: Early joint or muscle bleed Severe epistaxis Loading dose 15 IU FVIII:C/kg to achieve a FVIII:C plasma level of approximately 30% of normal; one infusion may be sufficient.

If needed, half of the loading dose may be given once or twice daily for 1-2 days. Moderate hemorrhage: Advanced joint or muscle bleed Neck, tongue, or pharyngeal hematoma (without airway compromise) Tooth extraction Severe abdominal pain Loading dose 25 IU FVIII:C/kg to achieve a FVIII:C plasma level of approximately 50% of normal, followed by 15 IU FVIII:C/kg every 8-12 hours for the first 1-2 days to maintain the FVIII:C plasma level at 30% of normal. Continue the same dose once or twice daily for up to 7 days or until adequate wound healing is achieved.

Life-threatening hemorrhage: Major surgery Gastrointestinal bleeding Neck, tongue, or pharyngeal hematoma (with potential for airway compromise) Intracranial, intraabdominal, or intrathoracic bleeding Fractures Initially 40-50 IU FVIII:C/kg, followed by 20-25 IU FVIII:C/kg every 8 hours to maintain the FVIII:C plasma level at 80-100% of normal for 7 days. Continue the same dose once or twice daily for another 7 days to maintain the FVIII:C level at 30-50% of normal.

2.2Treatment of Bleeding Episodes in VWD Administer 40 to 80 International Units (IU) VWF:RCo (corresponding to 17 to 33 International Units (IU) FVIII in Humate-P) per kg body weight every 8 to 12 hours. Adjust the dosage based on the extent and location of bleeding. Administer repeat doses as long as needed based on monitoring of appropriate clinical and laboratory measures ( see Warnings and Precautions [5.2 and 5.3] ).

Expected levels of VWF:RCo are based on an expected in vivo recovery (IVR) of

2.0International Units (IU)/dL rise per International Unit (IU)/kg VWF:RCo administered. The administration of 1 International Unit (IU) of FVIII per kg body weight can be expected to lead to a rise in circulat… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 158 words ▾

3 DOSAGE FORMS AND STRENGTHS Humate-P is a sterile, lyophilized powder for intravenous administration. Each vial of Humate-P contains the labeled amount of VWF:RCo and FVIII activity expressed in International Units (IU). The average ratio of VWF:RCo to FVIII is 2.4:1.

Approximate potencies are shown below; check each carton/vial for the actual potency prior to reconstitution: VWF:RCo/vial FVIII/vial Diluent * IU = International Units. 600 IU 250 IU 5 mL 1200 IU 500 IU 10 mL 2400 IU 1000 IU 15 mL Each vial of Humate-P lyophilized powder contains the labeled amount of VWF:RCo and FVIII activity expressed in IU IU = International Units. . The average ratio of VWF:RCo to FVIII is 2.4:1.

Approximate potencies are shown below; check each carton/vial for the actual potency prior to reconstitution ( 3 ): VWF:RCo/vial FVIII/vial Diluent * IU = International Units. 600 IU 250 IU 5 mL 1200 IU 500 IU 10 mL 2400 IU 1000 IU 15 mL

⛔ Contraindications 38 words ▾

4 CONTRAINDICATIONS Humate-P is contraindicated in individuals who have had an anaphylactic or severe systemic reaction to antihemophilic factor or von Willebrand factor preparations. Anaphylactic or severe systemic reaction to antihemophilic factor or VWF preparations ( 4 ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS VWD patients receiving Humate-P may be at risk of developing thromboembolic events ( 5.1 ). Monitor for intravascular hemolysis and decreasing hematocrit values in patients with A, B, and AB blood groups who are receiving large or frequent doses ( 5.2 ). Monitor VWF:RCo and FVIII levels in VWD patients, especially those undergoing surgery ( 5.3 ).

Products made from human plasma may contain infectious agents (e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent ( 5.4 ).

5.1Thromboembolic Events (VWD Patients) Thromboembolic events have been reported in VWD patients receiving Antihemophilic Factor/von Willebrand Factor Complex replacement therapy, especially in the setting of known risk factors for thrombosis. 3,4 Early reports indicate a higher incidence may occur in females. Endogenous high levels of FVIII have also been associated with thrombosis, but no causal relationship has been established.

Exercise caution and consider antithrombotic measures in all at-risk VWD patients who are receiving coagulation factor replacement therapy.

5.2Monitoring for Intravascular Hemolysis Humate-P contains blood group isoagglutinins (anti-A and anti-B). When doses are very large or need to be repeated frequently (for example, when inhibitors are present or when pre- and post-surgical care is involved), monitor patients of blood groups A, B, and AB for signs of intravascular hemolysis and decreasing hematocrit values and treat appropriately.

5.3Monitoring VWF:RCo and FVIII Levels Monitor the VWF:RCo and FVIII levels of VWD patients receiving Humate-P using standard coagulation tests, especially in cases of surgery. It is advisable to monitor trough VWF:RCo and FVIII:C levels at least once a day in order to adjust the dosage of Humate-P as needed to avoid excessive accumulation of coagulation factors (s ee Dosage and Administration [2.2 , 2.3] ).

5.4Transmission of Infectious Agents Humate-P is made from human plasma. Products made from human plasma may contain infectious agents (e.g., viruses and theoretically, the Creutzfeldt-Jakob disease [CJD] agent) that can cause disease ( see Description [11] and Patient Counseling Information [17.1] ). The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses during manufacturing ( see Description [11.1] for virus reduction measures ).

Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Thus the risk of transmission of infectious agents cannot be eliminated completely.

Report all infections thought by a physician possibly to have been transmitted by this product to CSL Behring Pharmacovigilance at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Some viruses, such as Parvovirus B19 virus (B19V) or hepatitis A (HAV), are particularly difficult to remove or inactivate. B19V may most seriously affect pregnant women and immune-compromised individuals.

Although the overwhelming number of B19V and HAV cases are community acquired, reports of these infections have been associated with the use of some plasma-derived products. Therefore, physicians should be alert to the potential symptoms of B19V and HAV infections ( see Patient Counseling Information [17.1] ). Symptoms of B19V may include low-grade fever, rash, arthralgias, and transient symmetric, nondestructive arthritis.

Diagnosis is often established by measuring B19V-specific IgM and IgG antibodies. Symptoms of HAV include low-grade fever, anorexia, nausea, vomiting, fatigue, and jaundice. A diagnosis may be established by measuring specific IgM antibodies.

Physicians should strongly consider administration of hepatitis A and hepatitis B vaccines to individuals re… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most serious adverse reaction observed in patients receiving Humate-P is anaphylaxis. Thromboembolic events have also been observed in patients receiving Humate-P for the treatment of VWD ( see Warnings and Precautions [5.1] ). Reports of thromboembolic events in VWD patients with other thrombotic risk factors receiving coagulation factor replacement therapy have been obtained from spontaneous reports, published literature, and a European clinical study.

In some cases, inhibitors to coagulation factors may occur. However, no inhibitor formation was observed in any of the clinical studies. In patients receiving Humate-P in clinical studies for treatment of VWD, the most commonly reported adverse reactions observed by >5% of subjects are allergic-anaphylactic reactions (including urticaria, chest tightness, rash, pruritus, and edema).

For patients undergoing surgery, the most common adverse reactions are postoperative wound and injection-site bleeding, and epistaxis. Most common adverse reactions observed by >5% of subjects after receiving Humate-P are allergic-anaphylactic reactions (e.g., urticaria, chest tightness, rash, pruritus, edema) and, in patients undergoing surgery, postoperative wound and injection-site bleeding, and epistaxis ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring Pharmacovigilance at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice. Treatment of Bleeding Episodes in VWD Allergic symptoms, including allergic reaction, urticaria, chest tightness, rash, pruritus, and edema, were reported in 6 of 97 (6%) subjects in a Canadian retrospective study ( see Clinical Studies [14.1] ). Four of 97 (4%) subjects experienced seven adverse events that were considered to have a possible or probable relationship to Humate-P.

These included chills, phlebitis, vasodilation, paresthesia, pruritus, rash, and urticaria. All were mild in intensity with the exception of a moderate case of pruritus. In a prospective, open-label safety and efficacy study of Humate-P in VWD subjects with serious life- or limb-threatening bleeding or undergoing emergency surgery, seven of 71 (10%) subjects experienced nine adverse reactions.

These were one occurrence each of mild vasodilation and mild pruritis; two occurrences of mild paresthesia; and one occurrence each of moderate peripheral edema and extremity pain and severe pseudothrombocytopenia (platelet clumping with a false low reading). Humate-P was discontinued in the subject who experienced the peripheral edema and extremity pain. Prevention of Excessive Bleeding During and After Surgery in VWD Among the 63 VWD subjects who received Humate-P for prevention of excessive bleeding during and after surgery, including one subject who underwent colonoscopy without the planned polypectomy, the most common adverse events were postoperative hemorrhage (35 events in 19 subjects with five subjects experiencing bleeding at up to three different sites), postoperative nausea (15 subjects), and postoperative pain (11 subjects).

Table 5 presents the postoperative hemorrhagic adverse events. Table 5: Hemorrhagic Adverse Events in 63 Surgical Subjects Adverse Event Surgical Procedure Category Number of Subjects/Events Onset On = on-therapy; onset while receiving Humate-P or within 1 day of completing Humate-P administration. Post = post-therapy; onset at least one day after completing Humate-P administration.

(Number of Events) Severity (Number of Events) On Post Mild Mod Severe Wound/injection site bleeding Major 8/11 7 4 9 – 2 Minor 2/2 2 – 1 1 – Oral 2/6 – 6 3 3 – Epistaxis Major 4/4 2 2 3 1 – Minor 1/1 1 – 1 – – Cerebral hemorrhage/ subdural hematoma Major 1/2 2 Reported as serious adverse events… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 5 words ▾

7 DRUG INTERACTIONS None reported.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: No human or animal data. Use only if clearly needed ( 8.1 ). The hemostatic efficacy of Humate-P has been studied in 34 pediatric subjects with VWD ( 8.4 ). Based on the data from a subset of these subjects, age had no effect on the pharmacokinetics of VWF:RCo ( 12.3 ).

8.1Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with Humate-P. It is also not known whether Humate-P can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Humate-P should be given to a pregnant woman only if clearly needed.

8.2Labor and Delivery It is not known whether Humate-P can cause harm to the mother or the fetus when administered during labor and delivery. Humate-P should be given during labor and delivery only if clearly needed.

8.3Nursing Mothers It is not know whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Humate-P is administered to a nursing woman.

8.4Pediatric Use Hemophilia A Adequate and well-controlled studies with long-term evaluation of joint damage have not been done in pediatric subjects. Joint damage may result from suboptimal treatment of hemarthroses. VWD The safety and effectiveness of Humate-P for the treatment of VWD was demonstrated in 26 pediatric subjects, including infants, children, and adolescents, but have not been evaluated in neonates.

The safety of Humate-P for the prevention of excessive bleeding during and after surgery was demonstrated in eight pediatric subjects (ages 3 to 15) with VWD. Of the 34 pediatric subjects studied for either treatment of bleeding episodes in VWD or prevention of excessive bleeding during and after surgery, four were infants (1 month to under 2 years of age), 23 were children (2 through 12 years), and seven were adolescents (13 through 15 years). As in adults, pediatric patients should be dosed based on body weight (kg) ( see Dosage and Administration [2.2 , 2.3] ).

8.5Geriatric Use Clinical studies of Humate-P did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects. As for all patients, dosing for geriatric patients should be appropriate to their overall situation.

🤰 Pregnancy 48 words ▾

8.1Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with Humate-P. It is also not known whether Humate-P can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Humate-P should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 158 words ▾

8.4Pediatric Use Hemophilia A Adequate and well-controlled studies with long-term evaluation of joint damage have not been done in pediatric subjects. Joint damage may result from suboptimal treatment of hemarthroses. VWD The safety and effectiveness of Humate-P for the treatment of VWD was demonstrated in 26 pediatric subjects, including infants, children, and adolescents, but have not been evaluated in neonates.

The safety of Humate-P for the prevention of excessive bleeding during and after surgery was demonstrated in eight pediatric subjects (ages 3 to 15) with VWD. Of the 34 pediatric subjects studied for either treatment of bleeding episodes in VWD or prevention of excessive bleeding during and after surgery, four were infants (1 month to under 2 years of age), 23 were children (2 through 12 years), and seven were adolescents (13 through 15 years). As in adults, pediatric patients should be dosed based on body weight (kg) ( see Dosage and Administration [2.2 , 2.3] ).

🧓 Geriatric Use 44 words ▾

8.5Geriatric Use Clinical studies of Humate-P did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects. As for all patients, dosing for geriatric patients should be appropriate to their overall situation.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The active components of Humate-P consist of two different noncovalently bound proteins (FVIII and VWF). FVIII is an essential cofactor in activation of factor X, leading ultimately to the formation of thrombin and, subsequently, fibrin. VWF promotes platelet aggregation and platelet adhesion on damaged vascular endothelium; activated platelets interact with clotting proteins to form a clot.

VWF also serves as a stabilizing carrier protein for the procoagulant protein FVIII. 7,8 The activity of VWF is measured as VWF:RCo.

12.3Pharmacokinetics Hemophilia A After infusion of Humate-P, a rapid increase of plasma FVIII:C is followed by a rapid decrease in activity and, subsequently, a slower rate of decrease in activity. Studies with Humate-P in subjects with hemophilia A have demonstrated a mean half-life of 12.2 (range: 8.4 to 17.4) hours. VWD The pharmacokinetics of Humate-P were studied in 41 subjects in a US study and in 28 subjects in a European study ( see Clinical Studies [14.2] ).

In both studies, subjects were evaluated in the nonbleeding state prior to a surgical procedure. Table 8 summarizes the pharmacokinetics of Humate-P based on these studies. Wide inter-subject variability was observed in pharmacokinetic values obtained from these studies.

Table 8: Pharmacokinetics of Humate-P in Two Studies of Subjects in the Non-Bleeding State Prior to Surgery US Study European Study IU = International Units. BW = body weight. Number of subjects Type 1 VWD Type 2A VWD Type 2B VWD Type 2M VWD Type 3 VWD 41 16 2 4 6 13 28 10 10 -- 1 7 Dosage of Humate-P 60 IU VWF:RCo/kg BW 80 IU VWF:RCo/kg BW Median terminal half-life of VWF:RCo (range) 11 hours Excluding 5 subjects with a half-life exceeding the blood sampling time of 24 or 48 hours.

(3.5-33.6) 10 hours Excluding 1 subject with a half-life exceeding the blood sampling time of 48 hours. (2.8-28.3) Median clearance (range) 3.1 mL/hr/kg (1-16.6) 4.8 mL/hr/kg (2.1-53) Volume of distribution at steady state (range) 53 mL/kg (29-141) 59 mL/kg (32-290) Median IVR for VWF:RCo activity (range)

2.4IU/dL per IU/kg (1.1-4.2)

1.9IU/dL per IU/kg (0.6-4.5) The multimeric patterns of Humate-P in the US study, were measured in 13 subjects with type 3 VWD; 11 had absent or barely detectable multimers at baseline. Of those 11 subjects, all had some high molecular weight multimers present 24 hours after infusion of Humate-P. In the European study, infusion of Humate-P corrected the defect of the multimer pattern in subjects with types 2A and 3 VWD.

High molecular weight multimers were detectable until at least 8 hours after infusion. Based on the small sample size evaluation, it appears that age, sex, and type of VWD have no impact on the pharmacokinetics of VWF:RCo.

🧬 Mechanism of Action 82 words ▾

12.1Mechanism of Action The active components of Humate-P consist of two different noncovalently bound proteins (FVIII and VWF). FVIII is an essential cofactor in activation of factor X, leading ultimately to the formation of thrombin and, subsequently, fibrin. VWF promotes platelet aggregation and platelet adhesion on damaged vascular endothelium; activated platelets interact with clotting proteins to form a clot.

VWF also serves as a stabilizing carrier protein for the procoagulant protein FVIII. 7,8 The activity of VWF is measured as VWF:RCo.

📦 How Supplied / Storage and Handling 158 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Humate-P is supplied in a single-dose vial containing the labeled amount of VWF:RCo and FVIII activity expressed in International Units (IU). Each package contains a vial of Humate-P, a vial of diluent containing sterile water (meets USP chemistry requirements Sterile Water for Injection, except for pH), a Mix2Vial filter transfer set, and two alcohol swabs. The components used in the packaging for Humate-P contain no latex.

Approximate potencies are shown below; check each carton/vial for the actual potency prior to reconstitution: NDC Number VWF:RCo/vial FVIII/vial Diluent IU = International Units. 63833-615-02 600 IU 250 IU 5 mL 63833-616-02 1200 IU 500 IU 10 mL 63833-617-02 2400 IU 1000 IU 15 mL When stored at temperatures up to 25°C (77°F), Humate-P is stable for 24 months up to the expiration date printed on its label. Do not freeze.

This product does not contain a preservative and should be used within 3 hours after reconstitution.

📦 Storage and Handling 42 words ▾

When stored at temperatures up to 25°C (77°F), Humate-P is stable for 24 months up to the expiration date printed on its label. Do not freeze. This product does not contain a preservative and should be used within 3 hours after reconstitution.

📋 Description ~3 min read ▾

11 DESCRIPTION Humate-P, Antihemophilic Factor/von Willebrand Factor Complex (Human), is a purified, sterile, lyophilized concentrate of Factor VIII (FVIII) and von Willebrand Factor (VWF) (Human) to be administered by the intravenous route in the treatment of patients with classical hemophilia (hemophilia A) and VWD ( see Clinical Pharmacology [12] ). Humate-P is purified from the cold insoluble fraction of pooled human plasma and contains purified and concentrated FVIII/VWF Complex (Human). Fibrinogen content is less than or equal to 0.2 mg/mL.

Each vial of Humate-P contains the labeled amount of von Willebrand Factor:Ristocetin Cofactor (VWF:RCo) and FVIII activity expressed in International Units (IU) ( see Dosage Forms and Strengths [3] ). An International Unit (IU) is defined by the current international standard established by the World Health Organization. One International Unit (IU) of VWF:RCo or FVIII is approximately equal to the amount of VWF:RCo or FVIII in 1.0 mL of fresh-pooled human plasma.

The average ratio of VWF:RCo to FVIII is 2.4:1. When reconstituted with the volume of diluent (sterile water) provided, each mL of Humate-P contains 72 to 224 International Units (IU) VWF:RCo activity This correlates to a VWF:RCo to FVIII activity average ratio of 2.4:1, which is used to calculate the nominal values of VWF:RCo activity and is the average VWF:RCo activity. , 40 to 80 International Units (IU) FVIII activity, 15 to 33 mg of glycine, 3.5 to 9.3 mg of sodium citrate, 2 to 5.3 mg of sodium chloride, 8 to 16 mg of Albumin (Human), 2 to 14 mg of other proteins, and 10 to 20 mg of total proteins.

Humate-P contains no preservative. Humate-P has been demonstrated in several studies to contain the high molecular weight multimers of VWF. This component is considered to be important for correcting the coagulation defect in patients with VWD.

5 When administered to patients with VWD (types 1, 2, or 3), bleeding time decreased. This outcome was correlated with the presence of a multimeric composition of VWF similar to that found in normal plasma. 6 Humate-P contains anti-A and anti-B blood group isoagglutinins ( see Warnings and Precautions [5.2] ).

The pooled human plasma used to produce Humate-P is collected from licensed facilities in the US. All source plasma used in the manufacture of Humate-P is tested by FDA-licensed Nucleic Acid Tests (NAT) for hepatitis C virus (HCV) and human immunodeficiency virus-1 (HIV-1) and found to be nonreactive (negative). The source plasma is also tested by an investigational NAT for hepatitis B virus (HBV) and found to be nonreactive (negative).

The purpose of the HBV test is to detect low levels of viral material; however, the significance of a nonreactive (negative) result has not been established.

11.1Virus Reduction Capacity The manufacturing procedure for Humate-P includes multiple processing steps that reduce the risk of virus transmission. The manufacturing process has been demonstrated to reduce the risk of virus transmission in an additive manner: 1) cryoprecipitation; 2) Al(OH) 3 adsorption, glycine precipitation, and NaCl precipitation, studied in combination; and 3) pasteurization in aqueous solution at 60°C for 10 hours. Total mean cumulative virus reductions ranged from 6.0 to ≥11.3 log 10 as shown in Table 7.

Table 7: Mean Virus Reduction Factors Virus Studied Cryoprecipitation Al(OH) 3 Adsorption / Glycine Precipitation / NaCl Precipitation Pasteurization Mean Cumulative Virus Reduction [log 10 ] [log 10 ] [log 10 ] [log 10 ] ND, not determined; NA, not applicable; HIV-1, human immunodeficiency virus type 1, model for HIV types 1 and 2; BVDV, bovine viral diarrhea virus, model for HCV and WNV; PRV, pseudorabies virus, model for large enveloped DNA viruses (e.g., herpes virus); WNV, West Nile virus; HAV, hepatitis A virus; and CPV, canine parvovirus, model for Parvovirus B19 virus (B19V).

Enveloped Viruses HIV-1 ND 3.6 ≥6.4 ≥10.0 BVDV ND 2.4 ≥8.9 ≥11.3 PRV 1.6 3.7 4.6 9.9… [Excerpted — this section continues on DailyMed.]

💬 Information for Patients 122 words ▾

17 PATIENT COUNSELING INFORMATION Inform patients that Humate-P is made from human plasma (part of the blood) and may contain infectious agents that can cause disease (e.g., viruses and, theoretically, the CJD agent). Explain that the risk that Humate-P may transmit an infectious agent has been reduced by screening plasma donors, by testing the donated plasma for certain virus infections, and by inactivating and/or removing certain viruses during manufacturing ( see Warnings and Precautions [5.4] ). Inform patients that some viruses, such as B19V and HAV, may be particularly difficult to remove or inactivate.

Advise patients, especially pregnant women and immune-compromised individuals, to report low-grade fever, rash, joint pain, anorexia, nausea, vomiting, fatigue, and jaundice ( see Warnings and Precautions [5.4] ).

🍼 Nursing Mothers 35 words ▾

8.3Nursing Mothers It is not know whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Humate-P is administered to a nursing woman.

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Hemophilia A After infusion of Humate-P, a rapid increase of plasma FVIII:C is followed by a rapid decrease in activity and, subsequently, a slower rate of decrease in activity. Studies with Humate-P in subjects with hemophilia A have demonstrated a mean half-life of 12.2 (range: 8.4 to 17.4) hours. VWD The pharmacokinetics of Humate-P were studied in 41 subjects in a US study and in 28 subjects in a European study ( see Clinical Studies [14.2] ).

In both studies, subjects were evaluated in the nonbleeding state prior to a surgical procedure. Table 8 summarizes the pharmacokinetics of Humate-P based on these studies. Wide inter-subject variability was observed in pharmacokinetic values obtained from these studies.

Table 8: Pharmacokinetics of Humate-P in Two Studies of Subjects in the Non-Bleeding State Prior to Surgery US Study European Study IU = International Units. BW = body weight. Number of subjects Type 1 VWD Type 2A VWD Type 2B VWD Type 2M VWD Type 3 VWD 41 16 2 4 6 13 28 10 10 -- 1 7 Dosage of Humate-P 60 IU VWF:RCo/kg BW 80 IU VWF:RCo/kg BW Median terminal half-life of VWF:RCo (range) 11 hours Excluding 5 subjects with a half-life exceeding the blood sampling time of 24 or 48 hours.

(3.5-33.6) 10 hours Excluding 1 subject with a half-life exceeding the blood sampling time of 48 hours. (2.8-28.3) Median clearance (range) 3.1 mL/hr/kg (1-16.6) 4.8 mL/hr/kg (2.1-53) Volume of distribution at steady state (range) 53 mL/kg (29-141) 59 mL/kg (32-290) Median IVR for VWF:RCo activity (range)

2.4IU/dL per IU/kg (1.1-4.2)

1.9IU/dL per IU/kg (0.6-4.5) The multimeric patterns of Humate-P in the US study, were measured in 13 subjects with type 3 VWD; 11 had absent or barely detectable multimers at baseline. Of those 11 subjects, all had some high molecular weight multimers present 24 hours after infusion of Humate-P. In the European study, infusion of Humate-P corrected the defect of the multimer pattern in subjects with types 2A and 3 VWD.

High molecular weight multimers were detectable until at least 8 hours after infusion. Based on the small sample size evaluation, it appears that age, sex, and type of VWD have no impact on the pharmacokinetics of VWF:RCo.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Controlled clinical studies to evaluate the safety and efficacy of prophylactic dosing with Humate-P to prevent spontaneous bleeding have not been conducted in VWD subjects. Adequate data are not presently available on which to evaluate or to base dosing recommendations in this setting.

14.1Treatment of Bleeding Episodes in VWD Clinical efficacy of Humate-P in the control of bleeding in subjects with VWD was determined by a retrospective review of clinical safety and efficacy data obtained from 97 Canadian VWD subjects who received product under an Emergency Drug Release Program. The dosage schedule and duration of therapy were determined by the medical practitioner. There were 514 requests for product use for surgery, bleeding, or prophylaxis in the 97 subjects.

Of these, Humate-P was not used in 151 cases, and follow-up safety and/or efficacy information was available for 303 (83%) of the remaining 363 requests. In many cases, Humate-P from a single request was used for several treatment courses in one subject. Therefore, there are more reported treatment courses than requests.

Humate-P was administered to 97 subjects in 530 treatment courses: 73 for surgery, 344 for treatment of bleeding, and 20 for prophylaxis of bleeding. The majority of the 93 "other" uses involved dental procedures, diagnostic procedures, prophylaxis prior to a procedure, or test doses. Table 9 summarizes the dosing information (all subjects) for bleeding episodes.

Table 9: Dosing Information for Bleeding Episodes in VWD Type/Location of Bleeding Episode Digestive System Nose+Mouth +Pharynx Integument System Female Genital System Musculo-skeletal SD, standard deviation. No. of Subjects 14 29 11 4 22 Loading Dose Mean Dose (SD) IU VWF:RCo/kg. 62.1 (31.1) 66.9 (24.3) 73.4 (37.7) 88.5 (28.3) 50.2 (24.9) No. of Infusions Number of infusions where the dose per kg body weight was available.

37 127 22 7 107 Maintenance Dose Mean Dose (SD) 61.5 (38.0) 67.5 (22.4) 56.5 (63.3) 74.5 (17.7) 63.8 (28.8) No. of Infusions 250 55 4 15 121 No. of Treatment Days per Bleeding Episode Mean (SD) No. of Events 4.6 (3.6) 49 1.4 (1.2) 130 1.1 (0.4) 22 2.8 (2.9) 9 2.0 (1.9) 108 No. of Infusions by Treatment Day No. of Subjects 14 29 11 4 22 Day 1 Day 1, first treatment day. Mean (SD) No. of Events 1.2 (0.4) 49 1.1 (0.2) 130 1.0 (0.2) 22 1.0 (0.0) 9 1.0 (0.1) 108 No. of Subjects 13 9 3 1 15 Day 2 Mean (SD) No. of Events 1.2 (0.6) 41 1.3 (0.5) 12 1.0 (0.0) 3 1.0 (-) 1 1.2 (0.5) 26 No. of Subjects 12 6 - 2 10 Day 3 Mean (SD) No. of Events 1.5 (0.8) 25 1.4 (0.7) 9 - - 1.0 (0.0) 3 1.2 (0.4) 18

14.2Prevention of Excessive Bleeding During and After Surgery in VWD Two prospective, open-label, non-controlled, multicenter clinical studies, one in the US and one in Europe, investigated the safety and hemostatic efficacy of Humate-P in subjects with VWD undergoing surgery. • US clinical study – The primary objective of this study was to demonstrate the safety and hemostatic efficacy of Humate-P in preventing excessive bleeding in adult and pediatric subjects with VWD undergoing surgery. The 35 subjects (21 female and 14 male) ranged in age from 3 to 75 years (mean 32.9); seven were age 15 or younger and two were age 65 or older.

Twelve subjects had type 1 VWD, two had type 2A, three had type 2B, five had type 2M, and 13 had type 3. Twenty-eight of the surgical procedures were classified as major (e.g., orthopedic joint replacement, intracranial surgery, multiple tooth extractions, laparoscopic cholecystectomy), four as minor (e.g., placement of intravenous access device), and three subjects had oral surgery Oral surgery is defined as extraction of fewer than three teeth, if the teeth are non-molars and have no bony involvement. Extraction of more than one impacted wisdom tooth is considered major surgery due to the expected difficulty of the surgery and the expected blood loss, particularly in subjects with type 2A or type 3 VWD.

Extraction of more than two teeth is c… [Excerpted — this section continues on DailyMed.]

📚 References 149 words ▾

15 REFERENCES Levine PH, Brettler DB. Clinical aspects and therapy for hemophilia A. In: Hoffman R, Benz JB, Shattil SJ, Furie B, Cohen HJ, eds.

Hematology: Basic Principles and Practice . New York: Churchill Livingstone Inc.; 1991:1296-1297. Scott JP, Montgomery RT.

Therapy of von Willebrand disease. Semin Thromb Hemost. 1993;19:37-47.

Mannucci, PM. Venous Thromboembolism in Von Willebrand Disease. Thromb Haemostas.

2002;88:378-379. Markis M, Colvin B, Gupta V, Shields ML, Smith MP. Venous thrombosis following the use of intermediate purity FVIII concentrate to treat patients with von Willebrand's disease.

Thromb Haemostas. 2002;88:387-388. Berntorp E, Nilsson IM.

Biochemical and in vivo properties of commercial virus-inactivated factor VIII concentrates . Eur J Haematol. 1988;40:205-214.

Berntorp E. Plasma product treatment in various types of von Willebrand's disease. Haemostasis.

1994;24:289-297. Hoyer LW. The factor VIII complex: structure and function.

Blood. 1981;58:1-13. Meyer D, Girma J-P. von Willebrand factor: structure and function.

Thromb Haemostas. 1993;70:99-104.

📄 Package Label / Principal Display Panel 135 words ▾

Principal Display Panel - 250 IU Carton NDC 63833-615-02 One Vial and Diluent Antihemophilic Factor/ von Willebrand Factor Complex (Human) HUMATE-P ® Powder for Reconstitution For intravenous use only. I.U. VWF:RCo/vial I.U. FVIII/vial Expires: Lot no.: CSL Behring Principal Display Panel - 250 IU Carton

Principal Display Panel - 500 IU Carton NDC 63833-616-02 One Vial and Diluent Antihemophilic Factor/ von Willebrand Factor Complex (Human) HUMATE-P ® Powder for Reconstitution For intravenous use only. I.U. VWF:RCo/vial I.U. FVIII/vial Expires: Lot no.: CSL Behring Principal Display Panel - 500 IU Carton

Principal Display Panel - 1000 IU Carton NDC 63833-617-02 One Vial and Diluent Antihemophilic Factor/ von Willebrand Factor Complex (Human) HUMATE-P ® Powder for Reconstitution For intravenous use only. I.U. VWF:RCo/vial I.U. FVIII/vial Expires: Lot no.: CSL Behring Principal Display Panel - 1000 IU 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
369
Units reimbursed last 4 qtrs
1.9M
Gross reimbursed last 4 qtrs
$2.39M
Avg / prescription
$6,469.52
Avg / unit
$1.2372
Latest quarter Q1 2026
80Rx
Fee-for-service vs managed care ⓘ
69% FFS 31% MCO
Fee-for-service · 253 Rx Managed care · 116 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported 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: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 37,034 units · 1,159 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 209,389 units · 1,669 per 100k residents IL Indiana: 120,638 units · 1,758 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: 96,857 units · 1,383 per 100k residents MA California: 403,684 units · 1,036 per 100k residents CA Utah: no data reported UT Colorado: 49,409 units · 841 per 100k residents 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: 81,153 units · 749 per 100k residents 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: 243,283 units · 2,206 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 232,082 units · 761 per 100k residents TX Florida: 456,013 units · 2,017 per 100k residents FL
Units reimbursed · per 100k residents
7492,206
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 Georgia 2,206 /100k
2 Florida 2,017 /100k
3 Indiana 1,758 /100k
4 Illinois 1,669 /100k
5 Massachusetts 1,383 /100k
6 Nevada 1,159 /100k
7 California 1,036 /100k
8 Colorado 841 /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.

About this NDC listing & data coverage

Kit / multi-component package

Kit / multi-component package

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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
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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?
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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 CSL Behring GmbH. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
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Does this product have a billing J-code?
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Where does this data come from?
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← 63833-0615-02 · CSL 63833-0617-02 · CSL →
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.