Plasma derivative · BLA
Riastap (Fibrinogen human) NDC 63833-892
Fibrinogen human 2600 mg/100mL · Injection, Solution · Subcutaneous · CSL Behring GmbH
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63833-892-51 | 6383308925163833089251 | 1 VIAL, GLASS in 1 CARTON (63833-892-51) / 100 mL in 1 VIAL, GLASS (63833-892-90)Marketed from Jan 16, 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)
- Riastap
- Generic name (nonproprietary)
- fibrinogen human
- Active ingredients
- Fibrinogen human — 2600 mg/100mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- CSL Behring GmbHNDC labeler code 63833
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125317
- Marketing start
- Listing expires
- Other FDA classes
- Blood Coagulation Factors (Chemical structure)Increased Coagulation Activity (Physiologic effect)
- Identifiers
- Product ID 63833-892_703efe5b-eb9f-4690-abb8-e446feaa702fSPL ID 703efe5b-eb9f-4690-abb8-e446feaa702f
- 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 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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N463833089251followed by a unit qualifier and the quantityPackage 63833-0892-51. 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 63833-892
- What is NDC 63833-892?
- 63833-892 is the product NDC for Riastap (fibrinogen human), Fibrinogen human 2600 mg/100mL injection, solution, listed with the FDA by CSL Behring GmbH. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Riastap (Fibrinogen human).
- What is the active ingredient?
- Fibrinogen human.
- Who is the labeler?
- CSL Behring GmbH, NDC labeler code 63833. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Riastap?
- 1 other product NDC are listed under this name. See all Riastap NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Riastap products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| RiaSTAPfibrinogen human | Fibrinogen human 1300 mg/50mL | Injection, Powder, Lyophilized, For solutionIntravenous | CSL Behring GmbH | 63833-891 | 63833-0891-51 |
Other NDCs under BLA 125317
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 |
|---|---|---|---|---|
| RiaSTAPfibrinogen human | Fibrinogen human 1300 mg/50mL | Injection, Powder, Lyophilized, For solutionIntravenous | CSL Behring GmbH | 63833-891 |