Plasma derivative · BLA
Vistaseal (Human fibrinogen, human thrombin) NDC 61953-0020
Fibrinogen human 80 mg/mL; Human thrombin 500 [iU]/mL · Solution · Topical · GRIFOLS USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61953-0020-1 | 61953002001 | 1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION (61953-0020-1) / 2 mL in 1 SYRINGE, GLASS (61953-0020-2)Marketed from Nov 1, 2019 | |
| 61953-0020-3 | 61953002003 | 1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION (61953-0020-3) / 4 mL in 1 SYRINGE, GLASS (61953-0020-4)Marketed from Nov 1, 2019 | |
| 61953-0020-5 | 61953002005 | 1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION (61953-0020-5) / 6 mL in 1 SYRINGE, GLASS (61953-0020-6)Marketed from Nov 1, 2019 | |
| 61953-0020-7 | 61953002007 | 1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION (61953-0020-7) / 10 mL in 1 SYRINGE, GLASS (61953-0020-8)Marketed from Nov 1, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Vistaseal
- Generic name (nonproprietary)
- human fibrinogen, human thrombin
- Active ingredients
- Fibrinogen human — 80 mg/mLHuman thrombin — 500 [iU]/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- GRIFOLS USA, LLCNDC labeler code 61953
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125640
- 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 61953-0020_28f64c1d-b52d-4df0-b976-fe9c0cdd4170SPL ID 28f64c1d-b52d-4df0-b976-fe9c0cdd4170
- 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
N461953002001followed by a unit qualifier and the quantityPackage 61953-0020-01. 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 61953-0020
- What is NDC 61953-0020?
- 61953-0020 is the product NDC for Vistaseal, Fibrinogen human 80 mg/mL; Human thrombin 500 [iU]/mL solution, listed with the FDA by GRIFOLS USA, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vistaseal (Human fibrinogen, human thrombin).
- What is the active ingredient?
- Fibrinogen human, Human thrombin.
- Who is the labeler?
- GRIFOLS USA, LLC, NDC labeler code 61953. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vistaseal?
- 3 other product NDCs are listed under this name. See all Vistaseal NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vistaseal products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vistasealhuman fibrinogen, human thrombin | — | Kit | GRIFOLS USA, LLC | 61953-0011 | 61953-0011-01 |
| Vistasealhuman fibrinogen, human thrombin | — | Kit | GRIFOLS USA, LLC | 61953-0012 | 61953-0012-01 |
| Vistasealhuman fibrinogen, human thrombin | — | Kit | GRIFOLS USA, LLC | 61953-0014 | 61953-0014-01 |
Other NDCs under BLA 125640
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 |
|---|---|---|---|---|
| Vistasealhuman fibrinogen, human thrombin | — | Kit | GRIFOLS USA, LLC | 61953-0011 |
| Vistasealhuman fibrinogen, human thrombin | — | Kit | GRIFOLS USA, LLC | 61953-0012 |
| Vistasealhuman fibrinogen, human thrombin | — | Kit | GRIFOLS USA, LLC | 61953-0014 |