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HEMOFIL M antihemophilic factor human Kit — NDC 00944-3944-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

HEMOFIL M antihemophilic factor human Kit — NDC 0944-3944-02 (Billing 00944-3944-02)

by Takeda Pharmaceuticals America, Inc. · 1 KIT in 1 CARTON * 10 mL in 1 BOTTLE * 10 mL in 1 VIAL, GLASS

This is a package of HEMOFIL M antihemophilic factor human Kit from Takeda Pharmaceuticals America, Inc., marketed since Feb 1988 and currently FDA-listed. It is this product's only package size.

NDC 00944-3944-02
🏷️ FDA NDC (as labeled) 0944-3944-02 billing pads the labeler 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 0944-3944-02 alone.

Record
FDA NDC Directory package listing · Plasma derivative
Code segments
0944 labeler · 3944 product · 02 package
Package marketed since
Feb 23, 1988
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0944394402 6
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0944-3944-02
Product NDC 0944-3944
11-digit billing NDC 00944394402
NCPDP billing unit EA — each (per item)
Application # BLA101448
SPL Set ID b8953ff7-3bba-4a0b-a486-f26fb81f05d9
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1988-02-23
Dosage form KIT
Biologic (Purple Book) 351(a)

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

GPI-14 85100010002140
GPI class Hemofil M
GCN Seq No 067605
GCN 30193
HICL code 011417
Ingredient (HICL) Antihemophilic Factor, Human
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 HEMOFIL M 1,000 UNIT NOMINAL
FDB brand name Hemofil M
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 067605
  • GCN: 30193
  • GPI-14 (Medi-Span): 85100010002140
  • HICL (First Databank): 011417
  • AHFS class code: 20:28.16.00
Why two NDCs? The FDA registers this code as 0944-3944-02 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00944-3944-02. 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 HEMOFIL M 1,000 UNIT NOMINAL Ingredient Antihemophilic Factor, Human

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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J7190 $1.246 / J7190 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)0944-3944-02
11-digit billing NDC00944-3944-02
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ7190
DescriptorFactor viii (antihemophilic factor, human) per i.u.
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))$2,660,691 · 72 claims · $36,954.03 per claim (all NDCs under J7190)
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
00944-3944-02 You're viewing this Main listing 1 KIT in 1 CARTON * 10 mL in 1 BOTTLE * 10 mL in 1 VIAL, GLASS 1988-02-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Hemofil Mthis 00944-3944-02 Takeda 1 kit — — FDA listed —
Hemofil M 00944-3946-02 Takeda 1 kit — — FDA listed —
Hemofil M 00944-3940-02 Takeda 1 kit — — FDA listed —
Hemofil M 00944-3942-02 Takeda 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

🏛️
2001
First FDA approval
Mar 2001
📍
2026
Currently FDA-listed
25 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.

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

LabelerTakeda Pharmaceuticals America, Inc.
FDA applicationBLA101448 (BLA)
Labeler code00944
First marketedFeb 1988
Product typePlasma Derivative
Portfolio154 products on file

More NDCs from Takeda Pharmaceuticals America, Inc. labeler code 00944

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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 32 words ▾

INDICATIONS AND USAGE The use of HEMOFIL M is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes. HEMOFIL M is not indicated in von Willebrand's disease.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION HEMOFIL M is to be administered only intravenously. The expected in vivo peak AHF level, expressed as IU/dL of plasma or % (percent) of normal, can be calculated by multiplying the dose administered per kg body weight (IU/kg) by two. This calculation is based on the clinical finding by Abildgaard, et al , 2 which is supported by data from the collaborative study of in vivo recovery and survival with 15 different lots of HEMOFIL M on 56 hemophiliacs that demonstrated a mean peak recovery point above the mean pre-infusion baseline of about

2.0IU/dL per infused IU/kg body weight. 3 Example: (1) A dose of 1750 IU AHF administered to a 70 kg patient, i.e., 25 IU/kg (1750/70), should be expected to cause a peak post-infusion AHF increase of 25 x 2 = 50 IU/dL (50% of normal). (2) A peak level of 70% is required in a 40 kg child.

In this situation the dose would be 70/2 x 40 = 1400 IU. Recommended Dosage Schedule Physician supervision of the dosage is required. The following dosage schedule may be used as a guide.

HEMORRHAGE Degree of hemorrhage Required peak post-infusion AHF activity in the blood (as % of normal or IU/dL plasma) Frequency of infusion Early hemarthrosis or muscle bleed or oral bleed 20-40 Begin infusion every 12 to 24 hours for one-three days until the bleeding episode as indicated by pain is resolved or healing is achieved. More extensive hemarthrosis, muscle bleed, or hematoma 30-60 Repeat infusion every 12 to 24 hours for usually three days or more until pain and disability are resolved. Life threatening bleeds such as head injury, throat bleed, severe abdominal pain 60-100 Repeat infusion every 8 to 24 hours until threat is resolved.

SURGERY Type of operation Minor surgery, including tooth extraction 60-80 A single infusion plus oral antifibrinolytic therapy within one hour is sufficient in approximately 70% of cases. Major surgery 80-100 (pre- and post-operative) Repeat infusion every 8 to 24 hours depending on state of healing. If bleeding is not controlled with the prescribed dose, the plasma level of Factor VIII should be determined and a sufficient dose of HEMOFIL M administered to achieve a satisfactory clinical response.

Under certain circumstances (e.g., presence of a low titer inhibitor) doses larger than those recommended may be necessary as per standard care. In patients with high titer Factor VIII inhibitors, HEMOFIL M therapy may not be effective and other therapeutic options should be considered. The dosage and duration of treatment depend on the severity of Factor VIII deficiency, the location and extent of the bleeding, and the patient’s clinical condition.

Careful control of replacement therapy is especially important in cases of major surgery or life threatening hemorrhages. Although dosage can be estimated by the calculations above, it is strongly recommended that whenever possible, appropriate laboratory tests including serial AHF assays be performed on the patient’s plasma at suitable intervals to assure that adequate AHF levels have been reached and are maintained. Reconstitution: Use Aseptic Technique Bring HEMOFIL M (dry concentrate) and Sterile Water for Injection, USP, (diluent) to room temperature.

Remove caps from concentrate and diluent bottles to expose central portion of rubber stoppers. Cleanse stoppers with germicidal solution. Remove protective covering from one end of double-ended needle and insert exposed needle through diluent stopper.

Remove protective covering from other end of double-ended needle. Invert diluent bottle over upright HEMOFIL M bottle, then rapidly insert free end of the needle through the HEMOFIL M bottle stopper at its center. The vacuum in the HEMOFIL M bottle will draw in the diluent.

Disconnect the two bottles by removing needle from diluent bottle stopper, then remove needle from HEMOFIL M bottle. Swirl gently until all material is dissolved. Be sure that HEMOFIL M is completely dissolved, otherwise active material will be remo… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 21 words ▾

CONTRAINDICATIONS HEMOFIL M is contraindicated in patients with a known hypersensitivity to the active substance, to excipients, or to mouse proteins.

⚠️ Warnings ~3 min read ▾

WARNINGS Hypersenitivity Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with HEMOFIL M and have been manifested by, for example, bronchospasm, dyspnea, hypotension, chest pain, facial edema, urticaria, rash, flushing, pruritus, nausea. Neutralizing Antibodies The development of neutralizing antibodies (inhibitors) to Factor VIII is a known complication of the treatment of patients with Hemophilia A. Inhibitors have predominantly been reported in previously untreated patients.

The risk of developing inhibitors is correlated to the extent of exposure to Factor VIII, the risk being highest within the first 20 exposure days, and to other genetic and environmental factors. The risk for inhibitor development depends on a number of factors relating to the characteristics of the patient (e.g., type of the Factor VIII gene mutation, family history, ethnicity), which are believed to represent the most significant risk factors for inhibitor formation. Transmission of Infectious Agents HEMOFIL M is made from human plasma.

Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. 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. Appropriate vaccination (against hepatitis A and B) should be considered for patients in regular/repeated receipt of plasma-derived products including HEMOFIL M.

Despite these measures, such products can still potentially transmit disease. Because this product is made from human plasma, a risk of transmitting infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Baxter Healthcare Corporation at 1-800-423-2862 (in the U.S.). The physician should discuss the risks and benefits of this product with the patient. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly non A, non B hepatitis.

As indicated under CLINICAL PHARMACOLOGY , however, a group of such patients treated with HEMOFIL M did not demonstrate signs or symptoms of non A, non B hepatitis over observation periods ranging from three to nine months.

Hypersenitivity Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with HEMOFIL M and have been manifested by, for example, bronchospasm, dyspnea, hypotension, chest pain, facial edema, urticaria, rash, flushing, pruritus, nausea.

Neutralizing Antibodies The development of neutralizing antibodies (inhibitors) to Factor VIII is a known complication of the treatment of patients with Hemophilia A. Inhibitors have predominantly been reported in previously untreated patients. The risk of developing inhibitors is correlated to the extent of exposure to Factor VIII, the risk being highest within the first 20 exposure days, and to other genetic and environmental factors.

The risk for inhibitor development depends on a number of factors relating to the characteristics of the patient (e.g., type of the Factor VIII gene mutation, family history, ethnicity), which are believed to represent the most significant risk factors for inhibitor formation.

Transmission of Infectious Agents HEMOFIL M is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. 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… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS Adverse Reactions from Clinical Trials The adverse reactions presented in this section have been identified based on clinical trial experience with HEMOFIL M in patients previously treated with other Factor VIII concentrates or blood products (N = 74), and previously untreated patients (PUPs; N = 50). Clinical Trial Adverse Reactions System Organ Class (SOC) Preferred MedDRA Term Number of Cases (Frequency Percentage) BLOOD AND LYMPHATIC SYSTEM DISORDERS Factor VIII inhibition 3 (5.7%) In a study that included 43 evaluable PUPs and 10 minimally treated patients (MTPs), i.e., patients with a single exposure to other Factor VIII concentrates or blood products, 3 of the total of 53 patients (5.7%) developed an inhibitor while on study.

NERVOUS SYSTEM DISORDERS Dizziness 1 (0.8%) Headache 1 (0.8%) Dysgeusia 1 (0.8%) GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pyrexia 1 (0.8%) Infusion site inflammation 2 (1.6%) HEMOFIL M was administered to 11 patients previously untreated with Antihemophilic Factor (Human). They have shown no signs of hepatitis or HIV infection following three to nine months of evaluation. A study of 25 patients treated with HEMOFIL M, and monitored for three to six months has demonstrated no evidence of antibody response to mouse protein.

More than 1,000 infusions of HEMOFIL M have been administered during the clinical trials. Reported events included a single episode each of chest tightness, fuzziness and dizziness, and one patient reported an unusual taste after each infusion. Post-marketing Adverse Reactions In addition to clinical trials, the following adverse reactions have been reported in the post-marketing experience, listed by MedDRA System Organ Class (SOC), then by Preferred Term.

IMMUNE SYSTEM DISORDERS: Anaphylaxis, Hypersensitivity reactions EYE DISORDERS: Visual impairment, Ocular hyperemia CARDIAC DISORDERS: Cyanosis, Bradycardia, Tachycardia VASCULAR DISORDERS: Hypotension, Flushing RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: Bronchospasm, Dyspnea, Cough, Hyperventilation GASTROINTESTINAL DISORDERS: Diarrhea, Vomiting, Nausea, Abdominal pain SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Urticaria, Rash, Pruritus, Hyperhidrosis GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Facial edema, Edema, Chills, Fatigue, Chest pain, Musculoskeletal pain, Irritability

Adverse Reactions from Clinical Trials The adverse reactions presented in this section have been identified based on clinical trial experience with HEMOFIL M in patients previously treated with other Factor VIII concentrates or blood products (N = 74), and previously untreated patients (PUPs; N = 50). Clinical Trial Adverse Reactions System Organ Class (SOC) Preferred MedDRA Term Number of Cases (Frequency Percentage) BLOOD AND LYMPHATIC SYSTEM DISORDERS Factor VIII inhibition 3 (5.7%) In a study that included 43 evaluable PUPs and 10 minimally treated patients (MTPs), i.e., patients with a single exposure to other Factor VIII concentrates or blood products, 3 of the total of 53 patients (5.7%) developed an inhibitor while on study.

NERVOUS SYSTEM DISORDERS Dizziness 1 (0.8%) Headache 1 (0.8%) Dysgeusia 1 (0.8%) GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pyrexia 1 (0.8%) Infusion site inflammation 2 (1.6%) HEMOFIL M was administered to 11 patients previously untreated with Antihemophilic Factor (Human). They have shown no signs of hepatitis or HIV infection following three to nine months of evaluation. A study of 25 patients treated with HEMOFIL M, and monitored for three to six months has demonstrated no evidence of antibody response to mouse protein.

More than 1,000 infusions of HEMOFIL M have been administered during the clinical trials. Reported events included a single episode each of chest tightness, fuzziness and dizziness, and one patient reported an unusual taste after each infusion.

Post-marketing Adverse Reactions In addition to clinical trials, the following adverse reactions have been… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 63 words ▾

Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with HEMOFIL M. The safety of HEMOFIL M for use in pregnant women has not been established. It is not known whether HEMOFIL M can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HEMOFIL M should be given to a pregnant woman only if clearly needed.

🧬 Clinical Pharmacology 65 words ▾

CLINICAL PHARMACOLOGY Antihemophilic factor (AHF) is a protein found in normal plasma which is necessary for clot formation. The administration of HEMOFIL M provides an increase in plasma levels of AHF and can temporarily correct the coagulation defect of patients with hemophilia A (classical hemophilia). The half-life of HEMOFIL M administered to Factor VIII deficient patients has been shown to be 14.8 ± 3.0 hours.

📦 How Supplied / Storage and Handling 62 words ▾

HOW SUPPLIED HEMOFIL M is available as single dose bottles that contain the following nominal potencies: Nominal Potency NDC Number 250 IU 0944-2930-01 500 IU 0944-2931-01 1000 IU 0944-2932-01 1700 IU 0944-2933-01 Each bottle is labeled with the potency in International Units, and is packaged together with 10 mL of Sterile Water for Injection, USP, a double-ended needle, and a filter needle.

📦 Storage and Handling 38 words ▾

STORAGE HEMOFIL M can be stored at 2° - 8°C (36° - 46°F) or at room temperature, not to exceed 30°C (86°F), until expiration date noted on the package. Avoid freezing to prevent damage to the diluent bottle.

📋 Description ~2 min read ▾

DESCRIPTION HEMOFIL M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified, is a sterile, nonpyrogenic, dried preparation of antihemophilic factor (Factor VIII, Factor VIII:C, AHF) in concentrated form with a specific activity range of 2 to 22 AHF International Units/mg of total protein. HEMOFIL M contains a maximum of 12.5 mg/mL Albumin, and per AHF International Unit, 0.07 mg polyethylene glycol (3350), 0.39 mg histidine as stabilizing agents, not more than 0.1 mg glycine, 0.1 ng mouse protein, 18 ng organic solvent (tri-n-butyl phosphate) and 50 ng detergent (octoxynol 9).

In the absence of the added Albumin (Human), the specific activity is approximately 2,000 AHF International Units/mg of protein. See CLINICAL PHARMACOLOGY . HEMOFIL M is prepared by the Method M process from pooled human plasma by immunoaffinity chromatography utilizing a murine monoclonal antibody to Factor VIII:C, followed by an ion exchange chromatography step for further purification.

Source material may be provided by other US licensed manufacturers. HEMOFIL M also includes an organic solvent (tri-n-butyl phosphate) and detergent (octoxynol 9) virus inactivation step designed to reduce the risk of transmission of hepatitis and other viral diseases. However, no procedure has been shown to be totally effective in removing viral infectivity from coagulation factor products.

Use of an organic solvent (tri-n-butyl phosphate; TNBP) in the manufacture of Antihemophilic Factor (Human) has little or no effect on AHF activity, while lipid enveloped viruses, such as hepatitis B and human immunodeficiency virus (HIV) are inactivated. 1 Each bottle of HEMOFIL M is labeled with the AHF activity expressed in International Units (IU) per bottle. This potency assignment is referenced to the World Health Organization International Standard.

The purity of HEMOFIL M has been thought to influence the difficulty of producing an accurate potency measurement. Experiments have shown that to achieve accurate activity levels, such a potency assay should be conducted using plastic test tubes and pipets as well as substrate containing normal levels of von Willebrand's Factor. In vitro studies demonstrate that the HEMOFIL M manufacturing process provides for significant viral reduction.

These studies, summarized in Table 1 , demonstrate virus clearance during the HEMOFIL M manufacturing process using human immunodeficiency virus, Type 1 (HIV-1); bovine viral diarrhea virus (BVDV), a generic model for lipid enveloped RNA viruses, such as hepatitis C virus (HCV); pseudorabies virus (PRV), a model for lipid enveloped DNA viruses, such as hepatitis B virus (HBV); canine parvovirus (CPV), a model for non-lipid enveloped DNA viruses, such as human parvovirus B19 (B19V); and hepatitis A virus (HAV). These reductions are achieved through a combination of process chemistry, partitioning and/or inactivation during solvent/detergent treatment and immunoaffinity chromatography.

Table 1 In Vitro Virus Clearance During the Manufacture of HEMOFIL M Process Step Evaluated Virus Clearance, log 10 Lipid-enveloped Non-Lipid enveloped HIV-1 BVDV PRV CPV HAV Solvent/Detergent Treatment >4.8 >6.8 >6.9 Solvent/Detergent treatment inactivates only lipid enveloped viruses. CPV and HAV are non-lipid enveloped viruses. Immunoaffinity Chromatography N.A.

Not Applicable for lipid enveloped viruses due to the presence of solvent/detergent in the starting material. N.A. N.A. ≥3.9 ≥4.5 Cumulative Total, log 10 >4.8 >6.8 >6.9 ≥3.9 ≥4.5

💬 Information for Patients 156 words ▾

Information for Patients Advise patients to report any adverse reactions or problems following HEMOFIL M administration to their physician or healthcare provider. Advise pregnant women or immune compromised individuals of the affects of Parvovirus B19 . Symptoms of parvovirus B19 infection include fever, drowsiness, chills, and runny nose followed about two weeks later by a rash, and joint pain.

Inform patients of the signs and symptoms of hepatitis A which include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly. Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physician if such symptoms appear.

Inform patients of the early signs of hypersensitivity reactions including hives, generalized urticaria, facial edema, flushing, nausea, tightness of the chest, wheezing, dyspnea, hypotension, and anaphylaxis . Advise patients to discontinue use of the product and contact their physician if these symptoms occur.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS Identification of the clotting defect as a Factor VIII deficiency is essential before the administration of HEMOFIL M is initiated. Factor VIII Inhibitors Patients should be evaluated for the development of Factor VIII inhibitors if the expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose. No benefit may be expected from this product in treating other deficiencies.

Formation of Antibodies to Mouse Protein HEMOFIL M contains trace amounts of mouse protein (less than 0.1 ng/AHF activity units). The possibility exists that patients treated with HEMOFIL M may develop hypersensitivity to the mouse proteins . There have been no cases of hypersensitivity to the mouse proteins reported.

Increase in Pulse Rate The pulse rate should be determined before and during administration of HEMOFIL M. Should a significant increase occur, reducing the rate of administration or temporarily halting the injection usually allows the symptoms to disappear promptly. Latex Sensitivity Certain components used in the packaging of this product contain natural rubber latex which may cause allergic reactions.

Use precaution when treating patients with sensitivity to natural rubber latex. Information for Patients Advise patients to report any adverse reactions or problems following HEMOFIL M administration to their physician or healthcare provider. Advise pregnant women or immune compromised individuals of the affects of Parvovirus B19 .

Symptoms of parvovirus B19 infection include fever, drowsiness, chills, and runny nose followed about two weeks later by a rash, and joint pain. Inform patients of the signs and symptoms of hepatitis A which include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly. Dark urine and a yellowed complexion are also common symptoms.

Patients should be encouraged to consult their physician if such symptoms appear. Inform patients of the early signs of hypersensitivity reactions including hives, generalized urticaria, facial edema, flushing, nausea, tightness of the chest, wheezing, dyspnea, hypotension, and anaphylaxis . Advise patients to discontinue use of the product and contact their physician if these symptoms occur.

Laboratory Tests Although dosage can be estimated by the calculations which follow, it is strongly recommended that whenever possible, appropriate laboratory tests be performed on the patient's plasma at suitable intervals to assure that adequate AHF levels have been reached and are maintained. If the AHF content of the patient's plasma fails to reach expected levels or if bleeding is not controlled after apparently adequate dosage, the presence of inhibitor should be suspected. By appropriate laboratory procedures, the presence of inhibitor can be demonstrated and quantified in terms of AHF units neutralized by each mL of plasma or by the total estimated plasma volume.

If the inhibitor is at low levels (i.e., <10 Bethesda Units/mL), after administration of sufficient AHF units to neutralize the inhibitor, additional AHF units will elicit the predicted response. Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with HEMOFIL M.

The safety of HEMOFIL M for use in pregnant women has not been established. It is not known whether HEMOFIL M can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HEMOFIL M should be given to a pregnant woman only if clearly needed.

Nursing Mothers The safety of HEMOFIL M for use in nursing mothers has not been established. It is not known whether this drug is excreted into human milk. Physicians should carefully consider the potential risks and benefits for each specific patient before prescribing HEMOFIL M.

HEMOFIL M should be given to nursing mothers only if clinically indicated.

Factor VIII Inhibitors Patients should be evaluated for the development of Factor VI… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 57 words ▾

Nursing Mothers The safety of HEMOFIL M for use in nursing mothers has not been established. It is not known whether this drug is excreted into human milk. Physicians should carefully consider the potential risks and benefits for each specific patient before prescribing HEMOFIL M. HEMOFIL M should be given to nursing mothers only if clinically indicated.

📚 References 134 words ▾

REFERENCES Horowitz B, Wiebe ME, Lippin A, et al: Inactivation of viruses in labile blood derivatives: 1. Disruption of lipid enveloped viruses by tri(n-butyl)phosphate detergent combinations. Transfusion 25 :516-522, 1985 Abildgaard CF, Simone JV, Corrigan JJ, et al: Treatment of hemophilia with glycine-precipitated Factor VIII.

New Eng J Med 275 :471-475, 1966 Addiego, Jr. JE, Gomperts E, Liu S. et al: Treatment of hemophilia A with a highly purified Factor VIII concentrate prepared by Anti-FVIIIc immunoaffinity chromatography. Thrombosis and Haemostasis 67 :19-27, 1992 To enroll in the confidential, industry-wide Patient Notification System, call 1-888-UPDATE U (1-888-873-2838) Baxter and Hemofil are trademarks of Baxter International Inc. and are registered in the U.S.

Patent and Trademark office. Baxter Healthcare Corporation Westlake Village, CA 91362 USA U.S. License No.

140 Printed in USA Revised Nov 10, 2010

📄 Package Label / Principal Display Panel ~2 min read ▾

Principle Display Panel HEMOFIL M 1000 unit carton 10 mL size, dried NDC 0944-2932-01 Antihemophilic Factor (Human) Method M, Monoclonal Purified HEMOFIL M FVIII For intravenous administration only. Administer within three hours after reconstitution is complete. See package insert for more information.

Store at 2°-8°C (38°-46°F) or room temperature, not to exceed 30°C (86°F) until the expiration date noted on the package. Avoid freezing to prevent damage to the diluent bottle. Sterile Nonpyrogenic No preservatives Warning : This product is prepared from large pools of human plasma.

Human blood and its components may transit infectious agents. The patient and the physician should discuss the risks and benefits of this product. Rx Only Read both front and back panels Baxter Healthcare Corporation Westlake Village , CA 91362 USA U.S.

License No. 140 Baxter and Hemofil are trademarks of Baxter International, Inc., and are registered in the U.S Patent and Trademark office. HEMOFIL M 1000 vial label 10 mL size, dried List 1501807 NDC 0944-2932-02 Antihemophilic Factor (Human) Method M, Monoclonal Purified HEMOFIL M FVII Store at 2°-8°C (38°-46°F) or room temperature, not to exceed 30°C (86°F) until the expiration date noted on the package.

See package insert for more information. Contains no preservative. For intravenous administration only.

Warning : This product is prepared from large pools of human plasma. Human blood and its components may transit infectious agents. The patient and the physician should discuss the risks and benefits of this product.

Rx Only Baxter Healthcare Corporation Westlake Village, CA 91362 USA U.S. License No. 140 Sterile Water vial label NDC 0338-0764-61 Nonpyrogenic Single-Dose Container 10 mL Sterile Water for Injection, USP for reconstitution of accompanying product Do not use unless clear.

No antimicrobial agent or other substance has been added. Do not use for intravascular injection without making approximately isotonic by injection of suitable solute. Discard unused portion.

Rx Only. This Product Contains Dry Natural Rubber. Baxter Manufactured by Baxter Healthcare Corporation Deerfield, IL 60015 USA HEMOFIL M 1000 unit carton HEMOFIL M 1000 vial label Sterile Water vial label

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

About this NDC listing & data coverage

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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Takeda Pharmaceuticals America, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Takeda Pharmaceuticals America, 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J7190 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.
← 00944-3942-02 · Takeda 00944-3946-02 · Takeda →
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.