Plasma derivative · BLA
Albuked (Albumin (human)) NDC 76125-791
Albumin human 10 g/50mL · Solution · Intravenous · KEDRION BIOPHARMA, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76125-791-10 | 7612507911076125079110 | 1 VIAL in 1 CARTON (76125-791-10) / 100 mL in 1 VIAL (76125-791-11)Marketed from Jul 28, 1981 | |
| 76125-791-50 | 7612507915076125079150 | 1 VIAL in 1 CARTON (76125-791-50) / 50 mL in 1 VIAL (76125-791-51)Marketed from Jul 28, 1981 |
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)
- Albuked
- Generic name (nonproprietary)
- albumin (human)
- Active ingredients
- Albumin human — 10 g/50mL
- Dosage form
- Solution
- Route
- Intravenous
- Labeler
- KEDRION BIOPHARMA, INC.NDC labeler code 76125
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 101138
- Marketing start
- Listing expires
- Other FDA classes
- Increased Intravascular Volume (Physiologic effect)Increased Oncotic Pressure (Physiologic effect)Osmotic Activity (Mechanism)Serum Albumin (Chemical/Ingredient)
- Identifiers
- Product ID 76125-791_0d86d9cc-a63a-4905-9620-deb24eed170eSPL ID 0d86d9cc-a63a-4905-9620-deb24eed170e
- Pharmacologic class
- Human Serum Albumin
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
N476125079110followed by a unit qualifier and the quantityPackage 76125-0791-10. 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 76125-791
- What is NDC 76125-791?
- 76125-791 is the product NDC for Albuked (albumin (human)), Albumin human 10 g/50mL solution, listed with the FDA by KEDRION BIOPHARMA, INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Albuked (Albumin (Human)).
- What is the active ingredient?
- Albumin human.
- Who is the labeler?
- KEDRION BIOPHARMA, INC., NDC labeler code 76125. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Albuked?
- 2 other product NDCs are listed under this name. See all Albuked NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Albuked products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Albukedalbumin (human) | Albumin human 2.5 g/50mL | SolutionIntravenous | KEDRION BIOPHARMA, INC. | 76125-790 | 76125-0790-0576125-0790-25 |
| Albukedalbumin (human) | Albumin human 5 g/20mL | SolutionIntravenous | KEDRION BIOPHARMA, INC. | 76125-792 | 76125-0792-1076125-0792-2076125-0792-25 |
Other NDCs under BLA 101138
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 |
|---|---|---|---|---|
| Albukedalbumin (human) | Albumin human 2.5 g/50mL | SolutionIntravenous | KEDRION BIOPHARMA, INC. | 76125-790 |
| Albukedalbumin (human) | Albumin human 5 g/20mL | SolutionIntravenous | KEDRION BIOPHARMA, INC. | 76125-792 |
| Plasbuminalbumin (human) | Albumin human 2.5 g/50mL | SolutionIntravenous | GRIFOLS USA, LLC | 13533-690 |
| Plasbuminalbumin (human) | Albumin human 10 g/50mL | SolutionIntravenous | GRIFOLS USA, LLC | 13533-691 |
| Plasbuminalbumin (human) | Albumin human 5 g/20mL | SolutionIntravenous | GRIFOLS USA, LLC | 13533-692 |