NDC codes

FDA NDC Directory
Product NDC (as listed)63713-461Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63713-0461Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
63713-461-0263713046102637130461022 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

N463713046102 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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