Plasma derivative · BLA
Albutein (albumin (human)) NDC 68516-5214
Albumin human 12.5 g/250mL · Injection, Solution · Intravenous · GRIFOLS USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68516-5214-1 | 68516521401 | 1 VIAL in 1 CARTON (68516-5214-1) / 250 mL in 1 VIAL (68516-5214-3)Marketed from Mar 1, 2022 | |
| 68516-5214-2 | 68516521402 | 1 VIAL in 1 CARTON (68516-5214-2) / 500 mL in 1 VIAL (68516-5214-4)Marketed from Mar 1, 2022 | |
| 68516-5214-5 | 68516521405 | 1 VIAL in 1 CARTON (68516-5214-5) / 50 mL in 1 VIAL (68516-5214-6)Marketed from Mar 1, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Albutein
- Generic name (nonproprietary)
- albumin (human)
- Active ingredients
- Albumin human — 12.5 g/250mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- GRIFOLS USA, LLC
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 102478
- 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 68516-5214_e078cf18-faac-4ebe-915a-acf9c1af960eSPL ID e078cf18-faac-4ebe-915a-acf9c1af960e
- 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
N468516521401followed by a unit qualifier and the quantityPackage 68516-5214-01. 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.
Other NDCs under BLA 102478
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 |
|---|---|---|---|---|
| Albuteinalbumin (human) | Albumin human 12.5 g/50mL | Injection, SolutionIntravenous | GRIFOLS USA, LLC | 68516-5216 |
| Albuteinalbumin (human) | Albumin human 10 g/50mL | Injection, SolutionIntravenous | GRIFOLS USA, LLC | 68516-5215 |
| Albuteinalbumin (human) | Albumin human 10 g/50mL | Injection, SolutionIntravenous | GRIFOLS USA, LLC | 68516-5215 |
| Albuteinalbumin (human) | Albumin human 12.5 g/250mL | Injection, SolutionIntravenous | GRIFOLS USA, LLC | 68516-5219 |
| Albuteinalbumin (human) | Albumin human 12.5 g/50mL | Injection, SolutionIntravenous | GRIFOLS USA, LLC | 68516-5216 |
| Albuteinalbumin (human) | Albumin human 12.5 g/250mL | Injection, SolutionIntravenous | GRIFOLS USA, LLC | 68516-5218 |