DigiFab (ovine digoxin immune fab) NDC 50633-120

NDC codes

FDA NDC Directory

Product NDC (as listed)50633-120Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50633-0120Add 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
50633-120-11	50633012011	1 VIAL, GLASS in 1 CARTON (50633-120-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (50633-120-12)Marketed from Aug 31, 2001

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): DigiFab
Generic name (nonproprietary): ovine digoxin immune fab
Active ingredients: Ovine digoxin immune fab — 40 mg/1
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: BTG International Inc.
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 103910
Marketing start: Aug 31, 2001
Listing expires: Dec 31, 2026
Other FDA classes: Cardiac Glycosides (Chemical structure)
Identifiers: Product ID 50633-120_617e1370-a75c-4d9e-8465-41abfe26025dSPL ID 617e1370-a75c-4d9e-8465-41abfe26025d
Pharmacologic class: Cardiac Glycoside

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

N450633012011 followed by a unit qualifier and the quantity

Package 50633-0120-11. 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 103910

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 103910
Product	Strength	Form · route	Labeler	Product NDC
DigiFabovine digoxin immune fab	Ovine digoxin immune fab 40 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous	Salvagenix Inc.	87131-120