Plasma derivative · BLA
Vistaseal (Human fibrinogen, human thrombin) NDC 61953-0011
Kit · GRIFOLS USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61953-0011-1 | 61953001101 | 1 KIT in 1 PACKAGE, COMBINATION (61953-0011-1) * 1 mL in 1 SYRINGE, GLASS * 1 mL in 1 SYRINGE, GLASSMarketed 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
- Dosage form
- Kit
- Labeler
- GRIFOLS USA, LLCNDC labeler code 61953
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125640
- Marketing start
- Marketing end
- Identifiers
- Product ID 61953-0011_54f6ba29-974e-400a-80d4-13c351229916SPL ID 54f6ba29-974e-400a-80d4-13c351229916
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N461953001101followed by a unit qualifier and the quantityPackage 61953-0011-01. 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 61953-0011
- What is NDC 61953-0011?
- 61953-0011 is the product NDC for Vistaseal kit, listed with the FDA by GRIFOLS USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vistaseal (Human fibrinogen, 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 | Fibrinogen human 80 mg/mL; Human thrombin 500 [iU]/mL | SolutionTopical | GRIFOLS USA, LLC | 61953-0020 | 61953-0020-0161953-0020-0361953-0020-05+1 more |
| 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 | Fibrinogen human 80 mg/mL; Human thrombin 500 [iU]/mL | SolutionTopical | GRIFOLS USA, LLC | 61953-0020 |
| Vistasealhuman fibrinogen, human thrombin | — | Kit | GRIFOLS USA, LLC | 61953-0012 |
| Vistasealhuman fibrinogen, human thrombin | — | Kit | GRIFOLS USA, LLC | 61953-0014 |