Plasma derivative · BLA
Evarrest (Fibrinogen human and human thrombin) NDC 63713-050
Fibrinogen human 8.6 mg/cm2; Human thrombin 37.5 [iU]/cm2 · Patch · Topical · Ethicon, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63713-050-24 | 63713005024 | 2 POUCH in 1 CARTON (63713-050-24) / 1 TRAY in 1 POUCH (63713-050-25) / 52 cm2 in 1 TRAYMarketed from Mar 1, 2013 |
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)
- Evarrest
- Generic name (nonproprietary)
- fibrinogen human and human thrombin
- Active ingredients
- Fibrinogen human — 8.6 mg/cm2Human thrombin — 37.5 [iU]/cm2
- Dosage form
- Patch
- Route
- Topical
- Labeler
- Ethicon, Inc.NDC labeler code 63713
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125392
- 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 63713-050_2dcbcc7a-19d2-db46-e063-6394a90a6b9bSPL ID 2dcbcc7a-19d2-db46-e063-6394a90a6b9b
- 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
N463713005024followed by a unit qualifier and the quantityPackage 63713-0050-24. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 63713-050
- What is NDC 63713-050?
- 63713-050 is the product NDC for Evarrest, Fibrinogen human 8.6 mg/cm2; Human thrombin 37.5 [iU]/cm2 patch, 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?
- Evarrest (Fibrinogen Human and Human Thrombin).
- What is the active ingredient?
- Fibrinogen human, 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 Evarrest?
- 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.