Plasma derivative · BLA
thrombin human NDC 63713-461
Human thrombin 2000 [iU]/2mL · Powder, For solution · Topical · Ethicon, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63713-461-02 | 6371304610263713046102 | 2 mL in 1 VIAL, GLASS (63713-461-02)Marketed from Sep 19, 2009 |
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)
- thrombin human
- Generic name (nonproprietary)
- thrombin human
- Active ingredients
- Human thrombin — 2000 [iU]/2mL
- Dosage form
- Powder, For solution
- Route
- Topical
- Labeler
- Ethicon, IncNDC labeler code 63713
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125247
- Marketing start
- Listing expires
- Other FDA classes
- Blood Coagulation Factors (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)
- Identifiers
- Product ID 63713-461_374e14e3-6a79-c213-e063-6394a90af910SPL ID 374e14e3-6a79-c213-e063-6394a90af910SPL set ID 02edcd44-1c26-45f1-a75c-f1f639d1956eRxCUI 748321UNII 6K15ABL77G
- 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
N463713046102followed by a unit qualifier and the quantityPackage 63713-0461-02. 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)
EVITHROM™ Thrombin, Topical (Human), is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. EVITHROM™ Thrombin, Topical (Human), may be used in conjunction with an Absorbable Gelatin Sponge, USP. EVITHROM™ is a topical thrombin indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical ( 1 ). EVITHROM™ may be use…
Excerpt only. Read the full label for complete information.
About NDC 63713-461
- What is NDC 63713-461?
- 63713-461 is the product NDC for thrombin human, Human thrombin 2000 [iU]/2mL powder, for solution, listed with the FDA by Ethicon, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- thrombin human.
- What is the active ingredient?
- Human thrombin.
- Who is the labeler?
- Ethicon, Inc, NDC labeler code 63713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for thrombin human?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.