Balfaxar (prothrombin complex concentrate (human)) NDC 68982-261

NDC codes

FDA NDC Directory

Product NDC (as listed)68982-261Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68982-0261Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68982-261-01	68982026101	1 VIAL, GLASS in 1 CARTON (68982-261-01) / 20 mL in 1 VIAL, GLASS (68982-261-81)Marketed from Nov 30, 2023
68982-261-02	68982026102	1 VIAL, GLASS in 1 CARTON (68982-261-02) / 40 mL in 1 VIAL, GLASS (68982-261-82)Marketed from Nov 30, 2023

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): Balfaxar
Generic name (nonproprietary): prothrombin complex concentrate (human)
Active ingredients: Coagulation factor ix human — 25.5 [iU]/mLProthrombin — 26 [iU]/mLCoagulation factor vii human — 16.5 [iU]/mLCoagulation factor x human — 24 [iU]/mLProtein c — 22 [iU]/mLProtein s human — 22 [iU]/mL
Dosage form: Powder, For solution
Route: Intravenous
Labeler: Octapharma USA Inc
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 125776
Marketing start: Nov 30, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Blood Coagulation Factors (Chemical structure)Blood Coagulation Factors (Chemical structure)Blood Coagulation Factors (Chemical structure)Blood Coagulation Factors (Chemical structure)Decreased Coagulation Factor Activity (Physiologic effect)Enzyme Precursors (Chemical structure)Increased Coagulation Activity (Physiologic effect)Increased Coagulation Activity (Physiologic effect)Increased Coagulation Activity (Physiologic effect)Increased Coagulation Activity (Physiologic effect)Protein C (Chemical structure)
Identifiers: Product ID 68982-261_5be10bd2-a785-7f3b-0d28-d066cd5f7d24SPL ID 5be10bd2-a785-7f3b-0d28-d066cd5f7d24
Pharmacologic class: Anti-coagulant; Blood Coagulation Factor; 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.

How CPT relates to drug billing

NDC on a medical claim

N468982026101 followed by a unit qualifier and the quantity

Package 68982-0261-01. 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.