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Profilnine factor ix complex Kit — NDC 68516-3210-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Profilnine factor ix complex Kit — NDC 68516-3210-1 (Billing 68516-3210-01)

by GRIFOLS USA, LLC · 1 KIT in 1 CARTON * 5 mL in 1 VIAL * 5 mL in 1 VIAL, GLASS

This is a package of Profilnine factor ix complex Kit from GRIFOLS USA, LLC, marketed since Jul 1981 and currently FDA-listed. It is this product's only package size.

NDC 68516-3210-01
🏷️ FDA NDC (as labeled) 68516-3210-1 billing pads the package segment with a zero
Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 2, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 68516-3210-1 alone.

Record
FDA NDC Directory package listing · Plasma derivative
Code segments
68516 labeler · 3210 product · 1 package
Package marketed since
Jul 20, 1981
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6851632101 0
FDA record last changed
Oct 2, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68516-3210-1
Product NDC 68516-3210
11-digit billing NDC 68516321001
NCPDP billing unit EA — each (per item)
Application # BLA102476
SPL Set ID 79821042-86a5-4a64-b621-76de0a0bbab2
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1981-07-20
Route INTRAVENOUS
Dosage form KIT
Biologic (Purple Book) 351(a)

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

GPI-14 85100030002105
GPI class Profilnine
GCN Seq No 006363
GCN 25142
HICL code 018940
Ingredient (HICL) Factor Ix Complx No.4,3-Factor
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M0
Therapeutic class — intermediate (HIC2) Blood And Blood Replacement Preparations
HIC3 code M0I
Therapeutic class — specific (HIC3) Factor Ix Complex (Pcc) Preparations
AHFS code 20:28.16.00
AHFS class Hemostatics
FDB label name PROFILNINE 500 UNIT VIAL
FDB brand name Profilnine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 006363
  • GCN: 25142
  • GPI-14 (Medi-Span): 85100030002105
  • HICL (First Databank): 018940
  • AHFS class code: 20:28.16.00
Why two NDCs? The FDA registers this code as 68516-3210-1 — a 5-4-1 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 package segment → 68516-3210-01. 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 PROFILNINE 500 UNIT VIAL Ingredient Factor Ix Complx No.4,3-Factor

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 · J7194 $1.747 / J7194 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)68516-3210-1
11-digit billing NDC68516-3210-01
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ7194
DescriptorFactor ix, complex, 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.
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
68516-3210-01 You're viewing this Main listing 1 KIT in 1 CARTON * 5 mL in 1 VIAL * 5 mL in 1 VIAL, GLASS 1981-07-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Profilninethis 68516-3210-01 GRIFOLS 1 kit — — FDA listed —
Profilnine 68516-3211-02 GRIFOLS 1 kit — — FDA listed —
Profilnine 68516-3212-02 GRIFOLS 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

🏛️
1981
First FDA approval
Jul 1981
📍
2026
Currently FDA-listed
45 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
Profilnine, Profilnine Hp, Profilnine Ht, Profilnine SdFactor IX Complex Proplex-T; BebulinFactor IX Complex
🔒 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

LabelerGRIFOLS USA, LLC
FDA applicationBLA102476 (BLA)
Labeler code68516
First marketedJul 1981
Product typePlasma Derivative
Portfolio52 products on file

More NDCs from GRIFOLS USA, LLC labeler code 68516

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 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 48 words ▾

INDICATIONS AND USAGE Factor IX Complex, Profilnine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. This product contains non-therapeutic levels of Factor VII, and is not indicated for use in the treatment of Factor VII deficiency.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION For adult usage: Factor IX Complex, Profilnine SD should be administered intravenously, promptly following reconstitution with the supplied diluent. Although Profilnine SD is stable for at least three (3) hours at room temperature after reconstitution, prompt administration is recommended to avoid the ill effect of any inadvertent bacterial contamination occurring during reconstitution. Profilnine SD may be administered by injection (plastic disposable syringe only) or infusion.

Administer at room temperature, do not refrigerate after reconstitution and discard any unused contents. Each vial of Profilnine SD is labeled with the total units expressed as International Units (IU) which is referenced to the WHO International Standard. One unit approximates the activity in one mL of normal plasma.

A 1.0% increase in Factor IX (0.01 IU)/IU administered/kg can be expected. 15 The amount of Profilnine SD required to establish hemostasis will vary with each patient and depend on the circumstances. The following formula may be used as a guide in determining the number of units to be administered: In normal clinical practice there is variability among patients and their clinical condition.

Therefore, the Factor IX level of each patient should be monitored frequently during replacement therapy. Mild to moderate hemorrhages may usually be treated with a single administration sufficient to raise the plasma Factor IX level to 20 to 30 percent. In the event of more serious hemorrhage, the patient's plasma Factor IX level should be raised to 30 to 50 percent.

Infusions are generally required daily. Surgery in patients with Factor IX deficiency requires that the Factor IX level should be raised to 30 to 50 percent for at least one week following operation. For dental extractions, the Factor IX level should be raised to 50 percent immediately prior to the procedure; additional Factor IX Complex may be given if bleeding recurs.

For pediatric usage: See PRECAUTIONS Equation RECONSTITUTION Use Aseptic Technique Warm diluent (Sterile Water for Injection, USP) and concentrate (Profilnine SD) to at least room temperature (but not above 37 °C). Remove the plastic flip off cap from the diluent vial. Gently swab the exposed stopper surface with a cleansing agent such as alcohol trying to avoid leaving any excess cleansing agent on the stopper.

Open the Mix2Vial ® package by peeling away the lid (Figure 1). Leave the Mix2Vial in the clear outer packaging. Place the diluent vial upright on an even surface and hold the vial tight and pick up the Mix2Vial in its clear outer packaging.

Holding the diluent vial securely, push the blue end of the Mix2Vial vertically down through the diluent vial stopper (Figure 2). While holding onto the diluent vial, carefully remove the clear outer packaging from the Mix2Vial set, ensuring the Mix2Vial remains attached to the diluent vial (Figure 3). Place the product vial upright on an even surface, invert the diluent vial with the Mix2Vial attached.

While holding the product vial securely on a flat surface, push the clear end of the Mix2Vial set vertically down through the product vial stopper (Figure 4). The diluent will automatically transfer out of its vial into the product vial. (NOTE: If the Mix2Vial is connected at an angle, the vacuum may be released from the product vial and the diluent will not transfer into the product vial.) With the diluent and product vials still attached to the Mix2Vial, gently swirl the product vial to ensure the product is fully dissolved (Figure 5).

Reconstitution requires less than 10 minutes. Do not shake the vial. Disconnect the Mix2Vial into two separate pieces (Figure 6) by holding each vial adapter and twisting counterclockwise.

After separating, discard the diluent vial with the blue end of the Mix2Vial. Draw air into an empty, sterile syringe. Keeping the product vial upright with the clear end of the Mix2Vial attached, screw the disposable syringe onto the… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 3 words ▾

CONTRAINDICATIONS None known.

⚠️ Warnings ~1 min read ▾

WARNINGS Because Factor IX Complex, Profilnine SD is made from pooled human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Stringent procedures designed to reduce the risk of adventitious agent transmission have been employed in the manufacture of this product, from the screening of plasma donors and the collection and testing of plasma to the application of viral elimination/reduction steps such as DEAE chromatography and solvent detergent treatment in the manufacturing process.

9-10 Despite these measures, such product can potentially transmit disease, therefore the risk of infectious agents cannot be totally eliminated. The physician should weigh the risks and benefits of the use of this product and should discuss these with the patient. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections.

Scientific opinion encourages hepatitis B and hepatitis A vaccinations for patients with hemophilia at birth or diagnosis. In patients undergoing surgery and in patients with known liver disease, thrombosis or disseminated intravascular coagulation (DIC) are serious and potentially fatal adverse reactions associated with the administration of Factor IX Complex concentrates. 11-13 Infrequent but consistent reports have been described which indicate that patients are at greater risk of developing thrombosis and DIC in the period following surgery.

Cases have also been cited which indicate that patients with liver disease may be predisposed to thrombosis or DIC when treated with Factor IX Complex. Although the available data is limited, Profilnine SD should only be administered to patients when the beneficial effects of use outweigh the serious risk of potential hypercoagulation.

🤒 Adverse Reactions 120 words ▾

ADVERSE REACTIONS Adverse reactions characterized by either thrombosis or disseminated intravascular coagulation (DIC) are associated with administration of Factor IX Complex concentrates. 11-14 In particular, patients who receive prolonged treatment with Factor IX Complex concentrates postoperatively or with known liver disease should be kept under close observation for signs or symptoms of intravascular coagulation. Continued administration should be left to the discretion of the physician.

Adverse reactions may include urticaria, fever, chills, nausea, vomiting, headache, somnolence, lethargy, flushing or tingling. For most reactive individuals, slowing the rate of infusion relieves the symptoms. For those highly reactive individuals, a different lot may be satisfactory.

To report SUSPECTED ADVERSE REACTIONS, contact Grifols at 1-888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🤰 Pregnancy 49 words ▾

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

🧒 Pediatric Use 95 words ▾

Pediatric Use Clinical Trials for safety and effectiveness in pediatric patients 16 years of age and younger have not been conducted. Across a well controlled half-life and recovery clinical trial in patients previously treated with factor IX concentrates for Hemophilia B, the two pediatric patients receiving Profilnine SD (solvent detergent treated) responded similarly when compared with the adult patients. There were no adverse events in the pediatric patients and one mild adverse event in the adult population (headache).

Anecdotal evaluation of the results indicate no safety and efficacy differences between pediatric and adult populations. 3

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Profilnine SD is a mixture of vitamin K-dependent clotting factors. The administration of Factor IX Complex, Profilnine SD, temporarily increases the plasma levels of Factor IX, thus minimizing the hazards of hemorrhage. A clinical study, which evaluated twelve subjects with hemophilia B, indicated that, following administration of Profilnine SD, Factor IX in vivo half-life is 24.68 ± 8.29 hours and recovery is 1.15 ±

0.16IU/dL per IU infused per kg body weight. 3 Administration of Factor IX Complex can result in higher than normal levels of Factor II due to its significantly longer half-life. 4 The retrovirus known as Human Immunodeficiency Virus (HIV-1) has been identified as the causative agent of Acquired Immunodeficiency Syndrome (AIDS) and has been shown to be transmissible via blood or blood products.

The solvent detergent process used in the manufacture of Profilnine SD has been shown to provide a very high level of virus kill without compromising protein structure and function. 5 The susceptibility of human pathogenic viruses such as HIV-1, hepatitis B virus, hepatitis C virus and marker viruses such as Sindbis and Vesicular Stomatitis Virus (VSV) to inactivation by organic solvent detergent treatment has been discussed in the literature. 6-8 The solvent detergent process used in the manufacture of Profilnine SD was shown to inactivate greater than 12.2 logs of HIV-1 when the retrovirus was intentionally added to product samples under laboratory evaluation (as measured by virus antigen capture and reverse transcriptase assays).

In addition, this process was shown to inactivate 6.0 logs of HIV-2 (as measured by reverse transcriptase assays) when the retrovirus was intentionally added to product samples. In order to assess the ability of the solvent detergent process to inactivate other viruses such as hepatitis B and C virus, the inactivation of the model viruses, Sindbis virus and vesicular stomatitis virus (VSV), by solvent detergent treatment was studied. Prior to solvent detergent treatment, samples were inoculated with a titer of either Sindbis or VSV.

The results demonstrated that a minimum of 5.3 logs of Sindbis and a minimum of 4.9 logs of VSV were removed after 180 minutes of incubation with solvent detergent (when compared to an untreated control). It should be noted that the incubation time in the actual Profilnine SD process is twice (360 minutes total) that used in the model virus studies. The ability of the Profilnine SD process to eliminate virus, by physically partitioning virus from product, was evaluated at the DEAE chromatography step.

Addition of Sindbis virus prior to Factor IX Complex adsorption by DEAE chromatography showed this step to eliminate 1.4 logs of added virus. However, no treatment method has yet been shown capable of totally eliminating all potential infective virus in preparations of coagulation factor concentrates.

📦 How Supplied / Storage and Handling 188 words ▾

HOW SUPPLIED Profilnine SD is supplied in sterile lyophilized form in single dose vials accompanied by a suitable volume of diluent (Sterile Water for Injection, USP), according to Factor IX potency. Each vial is labeled with the Factor IX potency expressed in International Units which is referenced to the WHO International Standard. Profilnine SD is packaged with a Mix2Vial filter transfer set for use in administration.

It is available in the following potencies, and the product is also color coded based upon assay on the carton and vial label as follows: Potency NDC Assay Color Code 500 IU FIX/5 mL single dose vial 68516-3201-1 500 IU FIX Range - blue box 1000 IU FIX/10 mL single dose vial 68516-3202-2 1000 IU FIX Range - red box 1500 IU FIX/10 mL single dose vial 68516-3203-2 1500 IU FIX Range - black box STORAGE Profilnine SD should be stored at temperatures between 2 and 8 °C. Do not freeze diluent. May be stored at room temperature not to exceed 30 °C for up to 3 months.

When removed from refrigeration, record the date on the vial or carton. Rx only

📦 Storage and Handling 47 words ▾

STORAGE Profilnine SD should be stored at temperatures between 2 and 8 °C. Do not freeze diluent. May be stored at room temperature not to exceed 30 °C for up to 3 months. When removed from refrigeration, record the date on the vial or carton. Rx only

📋 Description ~1 min read ▾

DESCRIPTION Factor IX Complex, Profilnine ® SD, Solvent Detergent Treated, is a sterile, lyophilized concentrate of Factor IX (antihemophilic factor B), Factor II (prothrombin), Factor X (Stuart-Prower Factor), and low levels of Factor VII (proconvertin) derived from human plasma. Factor II content has been assayed at no more than (NMT) 150 Units per 100 Factor IX Units, Factor X at NMT 100 Units per 100 Factor IX Units, and Factor VII at NMT 35 Units per 100 Factor IX Units. Profilnine SD is intended for intravenous administration only.

Each vial is a single dose container. Profilnine SD is a non-activated Factor IX Complex prepared from pooled human plasma and purified by DEAE cellulose adsorption. Profilnine SD is treated with a mixture of the organic solvent tri(n-butyl)phosphate (TNBP) and the nonionic detergent polysorbate 80 (Solvent Detergent Mixture) to reduce risks of transmission of viral infection.

However, no procedure has been shown to be totally effective in removing viral infectivity from coagulation factor products. Each vial of Profilnine SD is labeled with the Factor IX potency expressed in International Units (IU). Profilnine SD does not contain heparin.

Profilnine SD contains low levels of activated coagulation factors, as indicated by the non-activated Partial Thromboplastin Time Test. 1,2 Profilnine SD contains no preservatives. When reconstituted with the appropriate volume of Sterile Water for Injection, USP, Profilnine SD contains not more than 2.5 μg polysorbate 80 and 0.40 μg TNBP per IU of Factor IX.

💬 Information for Patients 104 words ▾

Information for Patients Patients should be informed of the early symptoms and signs of hypersensitivity reaction, including hives, generalized urticaria, chest tightness, dyspnea, wheezing, faintness, hypotension, and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care, depending on the severity of the reaction, if these symptoms occur. Some viruses, such as parvovirus B19 or hepatitis A, are particularly difficult to remove or inactivate at this time.

Parvovirus B19 may most seriously affect sero-negative pregnant women, or immunocompromised individuals. The majority of parvovirus B19 and hepatitis A infections are acquired by environmental (natural) sources.

⚠️ Precautions ~1 min read ▾

PRECAUTIONS General Factor IX Complex, Profilnine SD should not be administered at a rate exceeding 10 mL/minute. Rapid administration may result in vasomotor reactions. Nursing personnel, and others who administer this material, should exercise appropriate caution in handling due to the risk of exposure to viral infection.

Discard any unused contents. Discard administration equipment after single use. Do not resterilize components.

Do not reuse components. Information for Patients Patients should be informed of the early symptoms and signs of hypersensitivity reaction, including hives, generalized urticaria, chest tightness, dyspnea, wheezing, faintness, hypotension, and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care, depending on the severity of the reaction, if these symptoms occur.

Some viruses, such as parvovirus B19 or hepatitis A, are particularly difficult to remove or inactivate at this time. Parvovirus B19 may most seriously affect sero-negative pregnant women, or immunocompromised individuals. The majority of parvovirus B19 and hepatitis A infections are acquired by environmental (natural) sources.

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

Pediatric Use Clinical Trials for safety and effectiveness in pediatric patients 16 years of age and younger have not been conducted. Across a well controlled half-life and recovery clinical trial in patients previously treated with factor IX concentrates for Hemophilia B, the two pediatric patients receiving Profilnine SD (solvent detergent treated) responded similarly when compared with the adult patients. There were no adverse events in the pediatric patients and one mild adverse event in the adult population (headache).

Anecdotal evaluation of the results indicate no safety and efficacy differences between pediatric and adult populations. 3

📚 References ~1 min read ▾

REFERENCES Kingdon, H.S., Lundblad, R.L., Veltkamp, J.J., Aronson, D.L. Potentially thrombogenic materials in Factor IX Concentrates. Thromb Diath Haemorrh 33:617- 631, 1975.

Middleton, S.M., Forbes, C.D., Prentice, C.R.M. Thrombogenic Potential in Factor IX Concentrates Comparison of Tests. Thromb Haemost (Stuttg) 40:574-576, 1979.

Data on file at Grifols Biologicals Inc. Aronson, D.L. Factor IX Complex.

Semin Thromb Hemostas 6(1):28-43, 1979. Horowitz, B. Investigations into the Application of Tri(n-butyl) phosphate/Detergent Mixtures to Blood Derivatives.

In Viral Inactivation of Plasma Products , Morgenthaler J.J. (ed), Karger. Horowitz, B., Wiebe, M.E. et al.

Inactivation of viruses in labile blood derivatives. Transfusion 25:516-522, 1985. Edward, C.A., Piet, M.P.J. et al.

Tri(n-butyl)phosphate/detergent treatment of licensed therapeutic and experimental blood derivatives. Vox Sang 52:53-59, 1987. Prince, A.M., Horowitz, B., Horowitz, M. et al.

The development of virus-free labile blood derivatives-a review. Eur J Epidemiology , 3:103-118, 1987. Menache, D., Roberts, H.R.

Summary Report and Recommendations of the Task Force Members and Consultants. Thromb Diath Haemorrh 33:645-647, 1975. Carnelli, V., Gomperts, E.D., Friedman, A., et al.

Assessment for Evidence of Non A-Non B Hepatitis in Patients Given n-Heptane-Suspended Heat-Treated Clotting Factor Concentrate. Thromb Res , 46:827-834, 1987. Lusher, J.M.

Management of Hemophiliacs with Inhibitors. Hemophilia in the Child and Adult . Raven Press, Ltd., New York, 1989, pp.

121-136. Aledort, L.M. Factor IX and Thrombosis.

Scand J Haematol , Suppl 30:40-42, 1977. Kasper, C.K. Thromboembolic Complications.

Thromb Diath Haemorrh (Stuttg) 33:640-644, 1975. Chistolini, A., Mazzucconi, M.G., Tirindelli, M.L., LaVerde, G., Ferrari, A., Mandelli, F. Disseminated intravascular coagulation and myocardial infarction in a haemophilia B patient during therapy with prothrombin complex concentrate.

Acta Haematol 83:163-165, 1990. Zauber, N.P., Levin, J. Factor IX Levels in Patients with Hemophilia B (Christmas Disease) Following Transfusion with Concentrates of Factor IX or Fresh Frozen Plasma (FFP).

Medicine 56(3):213-224, 1977. Manufactured and Distributed by: Grifols Biologicals Inc. Los Angeles, CA 90032, U.S.A.

U.S. License No. 1694 DATE OF REVISION: August 2010 Part No.

📄 Package Label / Principal Display Panel 105 words ▾

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 500 IU VIAL GRIFOLS NDC 68516-3201-1 Factor IX Complex Profilnine ® SD MID Solvent Detergent Treated 5 mL Storage : Store between 2 and 8 °C. May be stored at room temperature not to exceed 30 °C for up to 3 months. Rx only. Single dose container for intravenous administration only. Grifols Biologicals Inc. Los Angeles, CA 90032, USA U.S. License No. 1694 Profilnine SD 500 IU VIAL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 500 IU CARTON GRIFOLS NDC 68516-3201-1 Factor IX Complex Profilnine ® SD Solvent Detergent Treated 5 mL MID Profilnine SD 500 IU CARTON

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 GRIFOLS USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
GRIFOLS USA, LLC 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 J7194 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.
← 68513-9296-09 · AbbVie 68516-3211-02 · GRIFOLS →
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.