Plasma derivative · BLA
Fibryga (fibrinogen (human)) NDC 68982-350
Fibrinogen human 20 mg/mL · Powder, For solution · Intravenous · Octapharma USA Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68982-350-01 | 68982035001 | 1 BOTTLE, GLASS in 1 CARTON (68982-350-01) / 100 mL in 1 BOTTLE, GLASS (68982-350-81)Marketed from Jun 23, 2025 |
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)
- Fibryga
- Generic name (nonproprietary)
- fibrinogen (human)
- Active ingredients
- Fibrinogen human — 20 mg/mL
- Dosage form
- Powder, For solution
- Route
- Intravenous
- Labeler
- Octapharma USA Inc
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125612
- Marketing start
- Listing expires
- Other FDA classes
- Blood Coagulation Factors (Chemical structure)Increased Coagulation Activity (Physiologic effect)
- Identifiers
- Product ID 68982-350_46907c4a-5b69-fff9-8ecc-32c6ed0ed480SPL ID 46907c4a-5b69-fff9-8ecc-32c6ed0ed480
- 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
N468982035001followed by a unit qualifier and the quantityPackage 68982-0350-01. 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.
Other NDCs under BLA 125612
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.