Plasma derivative · BLA
Plasbumin (Albumin (human)) NDC 13533-691
Albumin human 10 g/50mL · Solution · Intravenous · GRIFOLS USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13533-691-20 | 1353306912013533069120 | 1 VIAL in 1 CARTON (13533-691-20) / 50 mL in 1 VIAL (13533-691-21)Marketed from Sep 26, 1994 | |
| 13533-691-71 | 1353306917113533069171 | 1 VIAL in 1 CARTON (13533-691-71) / 100 mL in 1 VIAL (13533-691-72)Marketed from Sep 26, 1994 |
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)
- Plasbumin
- Generic name (nonproprietary)
- albumin (human)
- Active ingredients
- Albumin human — 10 g/50mL
- Dosage form
- Solution
- Route
- Intravenous
- Labeler
- GRIFOLS USA, LLCNDC labeler code 13533
- 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 13533-691_089f1f75-35f2-4ff2-884a-95a1f46f369dSPL ID 089f1f75-35f2-4ff2-884a-95a1f46f369d
- 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
N413533069120followed by a unit qualifier and the quantityPackage 13533-0691-20. 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 13533-691
- What is NDC 13533-691?
- 13533-691 is the product NDC for Plasbumin (albumin (human)), Albumin human 10 g/50mL solution, listed with the FDA by GRIFOLS USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Plasbumin (Albumin (Human)).
- What is the active ingredient?
- Albumin human.
- Who is the labeler?
- GRIFOLS USA, LLC, NDC labeler code 13533. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Plasbumin?
- 2 other product NDCs are listed under this name. See all Plasbumin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Plasbumin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Plasbuminalbumin (human) | Albumin human 2.5 g/50mL | SolutionIntravenous | GRIFOLS USA, LLC | 13533-690 | 13533-0690-2013533-0690-2513533-0690-27 |
| Plasbuminalbumin (human) | Albumin human 5 g/20mL | SolutionIntravenous | GRIFOLS USA, LLC | 13533-692 | 13533-0692-1613533-0692-2013533-0692-71 |
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 10 g/50mL | SolutionIntravenous | KEDRION BIOPHARMA, INC. | 76125-791 |
| 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 5 g/20mL | SolutionIntravenous | GRIFOLS USA, LLC | 13533-692 |