Plasma derivative · BLA
DigiFab (Ovine digoxin immune fab) NDC 50633-120
Ovine digoxin immune fab 40 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · BTG International Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50633-120-11 | 5063301201150633012011 | 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.NDC labeler code 50633
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103910
- Marketing start
- Marketing end
- Other FDA classes
- Cardiac Glycosides (Chemical structure)
- Identifiers
- Product ID 50633-120_5ca2559c-b619-0160-e063-6394a90a1675SPL ID 5ca2559c-b619-0160-e063-6394a90a1675
- 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.
- NDC on a medical claim
N450633012011followed by a unit qualifier and the quantityPackage 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.
About NDC 50633-120
- What is NDC 50633-120?
- 50633-120 is the product NDC for DigiFab (ovine digoxin immune fab), Ovine digoxin immune fab 40 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by BTG International Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- DigiFab (Ovine digoxin immune fab).
- What is the active ingredient?
- Ovine digoxin immune fab.
- Who is the labeler?
- BTG International Inc., NDC labeler code 50633. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for DigiFab?
- 1 other product NDC are listed under this name. See all DigiFab NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other DigiFab products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| DigiFabovine digoxin immune fab | Ovine digoxin immune fab 40 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Salvagenix Inc. | 87131-120 | 87131-0120-11 |
Other NDCs under BLA 103910
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 |
|---|---|---|---|---|
| DigiFabovine digoxin immune fab | Ovine digoxin immune fab 40 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Salvagenix Inc. | 87131-120 |