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THROMBIN-JMI thrombin, topical (bovine) Kit — NDC 60793-0217-22 package photo

THROMBIN-JMI thrombin, topical (bovine) Kit

by Pfizer Laboratories Div Pfizer Inc · 1 KIT in 1 CARTON (60793-217-22) * 20 mL in 1 VIAL, GLASS (60793-317-01) * 20 mL in 1 VIAL, GLASS (60793-221-09)
NDC 60793-0217-22
🏷️ FDA NDC (as labeled) 60793-217-22 billing pads the product segment with a zero
This package
Contains1 kit in 1 carton * 20 mL in 1 vial, glass * 20 mL in 1 vial, glass Pack sizes3 compare ↓
Also comes in: 1 kit 60793-0217-20 1 kit 60793-0217-21
Brand On market Non-controlled
🗂️ Data synced Sep 17, 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

🆔 Identity & classification

FDA NDC (as labeled) 60793-217-22
Product NDC 60793-217
11-digit billing NDC 60793021722
NCPDP billing unit EA — each (per item)
Application # BLA102865
SPL Set ID ba8fcebf-a924-488f-983d-088892761f0e
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1995-02-24
Dosage form KIT
GCN Seq No 069456
GCN 32511
HICL code 024462
Ingredient (HICL) Thrombin (Bovine)
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M9
Therapeutic class — intermediate (HIC2) Drugs Given To Alter Blood Coagulation
HIC3 code M9A
Therapeutic class — specific (HIC3) Topical Hemostatics
AHFS code 20:28.16.00
AHFS class Hemostatics
FDB label name THROMBIN-JMI 20,000 UNITS SYR
FDB brand name Thrombin-Jmi
Legend status F — Federal legend — prescription drug or device
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 60793-217-22 — 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 → 60793-0217-22. 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.

🏭 Manufacturer & labeler

LabelerPfizer Laboratories Div Pfizer Inc
FDA applicationBLA102865 (BLA)
Labeler code60793
First marketedFeb 1995
Product typePlasma Derivative
Portfolio242 products on file
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.

🩺 Clinical

Label name THROMBIN-JMI 20,000 UNITS SYR Ingredient Thrombin (Bovine)

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.

🧪 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.

💲 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 1 kit 1 kit
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Thrombin-Jmi 60793-0705-05 Pfizer 1 kit — — FDA listed —
Thrombin-Jmi 60793-0205-05 Pfizer 1 kit — — FDA listed —
Thrombin-Jmi 60793-0215-05 Pfizer 1 kit — — FDA listed —
Thrombin-Jmithis 60793-0217-22 Pfizer 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

🏛️
1986
First FDA approval
Feb 1986
📍
2026
Currently FDA-listed
40 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
Thrombin-Jmi, ThrombocollThrombin, Topical (Bovine)
🔒 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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 kit60793-0217-21 25 Rx · $3,377
1 kit60793-0217-20 No Medicaid data
1 kit this page60793-0217-22 No Medicaid data
Drug total (last 4 qtrs): 25 Rx · 13 units · $3,377 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
60793-0217-20 1 KIT in 1 CARTON (60793-217-20) * 20 mL in 1 VIAL, GLASS (60793-317-01) * 20 mL in 1 VIAL, GLASS (60793-221-09) 1995-02-24 Active
60793-0217-21 1 KIT in 1 CARTON (60793-217-21) * 20 mL in 1 VIAL, GLASS (60793-317-01) * 20 mL in 1 VIAL, GLASS (60793-221-09) 1995-02-24 Active
60793-0217-22 You're viewing this 1 KIT in 1 CARTON (60793-217-22) * 20 mL in 1 VIAL, GLASS (60793-317-01) * 20 mL in 1 VIAL, GLASS (60793-221-09) 1995-02-24 Active

Pack size FAQ

What quantity is in NDC 60793-0217-22?
NDC 60793-0217-22 is listed by the FDA — 1 kit in 1 carton * 20 ml in 1 vial, glass * 20 ml in 1 vial, glass.
What NDC number is used to bill for this package of THROMBIN-JMI thrombin, topical (bovine) Kit?
Bill NDC 60793-0217-22 — the 11-digit billing format is 60793021722. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 FDA registers it as 60793-217-22, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 60793-0217-22, written without dashes as 60793021722. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 60793-0217-22, the first segment (60793) is the labeler code FDA assigned to Pfizer Laboratories Div Pfizer Inc; the middle segment (0217) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (22) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Pfizer Laboratories Div Pfizer Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 kit (60793-0217-20), 1 kit (60793-0217-21). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Pfizer Laboratories Div Pfizer 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.
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.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🚨 Boxed Warning 149 words ▾

The use of topical bovine thrombin preparations has occasionally been associated with abnormalities in hemostasis ranging from asymptomatic alterations in laboratory determinations, such as prothrombin time (PT) and partial thromboplastin time (PTT), to severe bleeding or thrombosis which rarely have been fatal. These hemostatic effects appear to be related to the formation of antibodies against bovine thrombin and/or factor V which in some cases may cross react with human factor V, potentially resulting in factor V deficiency.

Repeated clinical applications of topical bovine thrombin increase the likelihood that antibodies against thrombin and/or factor V may be formed. Consultation with an expert in coagulation disorders is recommended if a patient exhibits abnormal coagulation laboratory values, abnormal bleeding, or abnormal thrombosis following the use of topical thrombin. Any interventions should consider the immunologic basis of this condition.

Patients with antibodies to bovine thrombin preparations should not be re-exposed to these products.

🎯 Indications and Usage 47 words ▾

INDICATIONS AND USAGE THROMBIN-JMI ® is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible. In various types of surgery, solutions of THROMBIN-JMI ® may be used in conjunction with an Absorbable Gelatin Sponge, USP for hemostasis.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Solutions of Thrombin, Topical (Bovine Origin), USP, THROMBIN-JMI ® may be reconstituted with sterile isotonic saline at a recommended concentration of 1,000 to 2,000 International Units/mL. Where bleeding is profuse, as from abraided surfaces of liver or spleen, concentrations of 1,000 International Units per mL may be required. For general use in plastic surgery, dental extractions, skin grafting, etc. solutions containing approximately 100 International Units/mL are frequently used.

Intermediate strengths to suit the needs of the case may be prepared by diluting the contents of the THROMBIN-JMI ® container with an appropriate volume of sterile isotonic saline. In many situations, it may be advantageous to use THROMBIN-JMI ® in a dry form on oozing surfaces. THROMBIN-JMI ® may also be used with FloSeal™ NT according to the directions for use in the FloSeal ™ NT package insert.

In instances where a concentration of approximately 1,000 units/mL is desired, the contents of the vial of sterile isotonic saline diluent may be transferred into the THROMBIN-JMI ® container with a sterile syringe or sterile transfer device. If the transfer device is used for reconstitution, transfer the diluent in the following manner. Remove the plastic cap off of the diluent vial.

Remove the tyvek cover from the transfer device container. Do not remove the device from the package. Seat the blue end of the device on the diluent vial, pushing down until the spike penetrates the diaphragm and the device snaps in place.

Flip the plastic cover off on the THROMBIN-JMI ® container. DO NOT REMOVE THE ALUMINUM SEAL. Remove the plastic package from the transfer device, taking care to not touch the exposed end of the device.

Invert the vial of diluent and insert the clear end of the transfer device into the diaphragm of the THROMBIN-JMI ® container. CAUTION: Solutions should be used promptly upon removal from the container. However, the solution may be refrigerated at 2°-8°C for up to 24 hours, or may be stored at room temperature for up to 8 hours after reconstitution.

⛔ Contraindications 34 words ▾

CONTRAINDICATIONS THROMBIN-JMI ® is contraindicated in persons known to be sensitive to any of its components and/or to material of bovine origin. Do not use for the treatment of massive or brisk arterial bleeding.

⚠️ Warnings 181 words ▾

WARNING The use of topical bovine thrombin preparations has occasionally been associated with abnormalities in hemostasis ranging from asymptomatic alterations in laboratory determinations, such as prothrombin time (PT) and partial thromboplastin time (PTT), to severe bleeding or thrombosis which rarely have been fatal. These hemostatic effects appear to be related to the formation of antibodies against bovine thrombin and/or factor V which in some cases may cross react with human factor V, potentially resulting in factor V deficiency.

Repeated clinical applications of topical bovine thrombin increase the likelihood that antibodies against thrombin and/or factor V may be formed. Consultation with an expert in coagulation disorders is recommended if a patient exhibits abnormal coagulation laboratory values, abnormal bleeding, or abnormal thrombosis following the use of topical thrombin. Any interventions should consider the immunologic basis of this condition.

Patients with antibodies to bovine thrombin preparations should not be re-exposed to these products. Because of its action in the clotting mechanism, THROMBIN-JMI ® must not be injected or otherwise allowed to enter large blood vessels. Extensive intravascular clotting and even death may result .

🤒 Adverse Reactions 33 words ▾

ADVERSE REACTIONS Allergic reactions may be encountered in persons known to be sensitive to bovine materials. Inhibitory antibodies which interfere with hemostasis may develop in a small percentage of patients. See WARNING .

🧬 Clinical Pharmacology 57 words ▾

CLINICAL PHARMACOLOGY THROMBIN-JMI ® requires no intermediate physiological agent for its action. It clots the fibrinogen of the blood directly. Failure to clot blood occurs in the rare case where the primary clotting defect is the absence of fibrinogen itself. The speed with which thrombin clots blood is dependent upon the concentration of both thrombin and fibrinogen.

📦 How Supplied / Storage and Handling 127 words ▾

HOW SUPPLIED THROMBIN-JMI ® is supplied in the following packages: NDC 60793-215-05 Vial: 5,000 IU vial with 5 mL diluent. NDC 60793-217-20 Vial: 20,000 IU vial with 20 mL diluent. THROMBIN-JMI ® Pump Spray Kit is supplied in the following packages: NDC 60793-217-21 Pump Spray Kit: 20,000 IU vial with 20 mL diluent, spray pump and actuator.

THROMBIN-JMI ® Syringe Spray Kit is supplied in the following packages: NDC 60793-705-05 Syringe Spray Kit: 5,000 IU vial with 5 mL diluent, spray tip and syringe. NDC 60793-217-22 Syringe Spray Kit: 20,000 IU vial with 20 mL diluent, spray tip and syringe. THROMBIN-JMI ® Epistaxis Kit is supplied in the following packages: NDC 60793-205-05 Epistaxis Kit: 5,000 IU vial with 5 mL diluent, nasal drug delivery device and syringe.

📋 Description 145 words ▾

DESCRIPTION The thrombin in Thrombin, Topical (Bovine Origin) THROMBIN-JMI ® is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine origin in the presence of calcium chloride. It is supplied as a sterile powder that has been freeze-dried in the final container. Also contained in the preparation are mannitol and sodium chloride.

Mannitol is included to make the dried product friable and more readily soluble. The material contains no preservative. THROMBIN-JMI ® has been chromatographically purified and further processed by ultrafiltration.

Analytical studies demonstrate the current manufacturing process’ capability to remove significant amounts of extraneous proteins, and result in a reduction of Factor Va light chain content to levels below the limit of detection of semi-quantitative Western Blot assay (<92 ng/mL, when reconstituted as directed). The clinical significance of these findings is unknown.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 60793-0215-05 · Pfizer 60793-0333-01 · Pfizer →
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.