Prescription drug · BLA
TachoSil (Thrombin human and fibrinogen) NDC 83078-702
Human thrombin 2 [USP'U]/1; Fibrinogen human 5.5 mg/1 · Patch · Topical · Corza Medical GmbH
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83078-702-02 | 83078070202 | 2 POUCH in 1 CARTON (83078-702-02) / 1 BLISTER PACK in 1 POUCH (83078-702-00) / 1 PATCH in 1 BLISTER PACK (83078-702-99)Marketed from Aug 29, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- TachoSil
- Generic name (nonproprietary)
- thrombin human and fibrinogen
- Active ingredients
- Human thrombin — 2 [USP'U]/1Fibrinogen human — 5.5 mg/1
- Dosage form
- Patch
- Route
- Topical
- Labeler
- Corza Medical GmbHNDC labeler code 83078
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125351
- Marketing start
- Listing expires
- Other FDA classes
- Blood Coagulation Factors (Chemical structure)Blood Coagulation Factors (Chemical structure)Increased Coagulation Activity (Physiologic effect)Increased Coagulation Factor Activity (Physiologic effect)
- Identifiers
- Product ID 83078-702_a6dcd8af-ccd7-4b27-880a-c7da5c7e6efcSPL ID a6dcd8af-ccd7-4b27-880a-c7da5c7e6efcSPL set ID 0c324332-290f-413f-820c-8c9a971a2766RxCUI 1001591, 1001593, 1014303, 1014305UNII 6K15ABL77G, N94833051K
- Pharmacologic class
- Human Blood Coagulation Factor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N483078070202followed by a unit qualifier and the quantityPackage 83078-0702-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. Limitations for Use TachoSil cannot safely or effectively be used in place of sutures or other form of mechanical ligation for the treatment of major arterial or venous bleeding. Not for use in children under one month of age. TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surge…
Excerpt only. Read the full label for complete information.
About NDC 83078-702
- What is NDC 83078-702?
- 83078-702 is the product NDC for TachoSil, Human thrombin 2 [USP'U]/1; Fibrinogen human 5.5 mg/1 patch, listed with the FDA by Corza Medical GmbH. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- TachoSil (THROMBIN HUMAN and FIBRINOGEN).
- What is the active ingredient?
- Human thrombin, Fibrinogen human.
- Who is the labeler?
- Corza Medical GmbH, NDC labeler code 83078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for TachoSil?
- 2 other product NDCs are listed under this name. See all TachoSil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other TachoSil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| TachoSilthrombin human and fibrinogen | Human thrombin 2 [USP'U]/1; Fibrinogen human 5.5 mg/1 | PatchTopical | Corza Medical GmbH | 83078-701 | 83078-0701-01 |
| TachoSilthrombin human and fibrinogen | Human thrombin 2 [USP'U]/1; Fibrinogen human 5.5 mg/1 | PatchTopical | Corza Medical GmbH | 83078-704 | 83078-0704-01 |
Other NDCs under BLA 125351
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| TachoSilthrombin human and fibrinogen | Human thrombin 2 [USP'U]/1; Fibrinogen human 5.5 mg/1 | PatchTopical | Corza Medical GmbH | 83078-701 |
| TachoSilthrombin human and fibrinogen | Human thrombin 2 [USP'U]/1; Fibrinogen human 5.5 mg/1 | PatchTopical | Corza Medical GmbH | 83078-704 |