Plasma derivative · BLA
Flexbumin (Albumin human) NDC 0944-0495
Albumin human .05 g/mL · Injection, Solution · Intravenous · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0944-0495-05 | 0094404950500944049505 | 2 BAG in 1 CARTON (0944-0495-05) / 250 mL in 1 BAG (0944-0495-06)Marketed from Jul 31, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Flexbumin
- Generic name (nonproprietary)
- albumin human
- Active ingredients
- Albumin human — .05 g/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 0944
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 101452
- 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 0944-0495_14185d93-8688-4431-9f2b-db36e3ef7ec5SPL ID 14185d93-8688-4431-9f2b-db36e3ef7ec5
- 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
N400944049505followed by a unit qualifier and the quantityPackage 00944-0495-05. 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 0944-0495
- What is NDC 0944-0495?
- 0944-0495 is the product NDC for Flexbumin (albumin human), Albumin human .05 g/mL injection, solution, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Flexbumin (Albumin Human).
- What is the active ingredient?
- Albumin human.
- Who is the labeler?
- Takeda Pharmaceuticals America, Inc., NDC labeler code 0944. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Flexbumin?
- 1 other product NDC are listed under this name. See all Flexbumin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Flexbumin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Flexbuminalbumin human | Albumin human .25 g/mL | SolutionIntravenous | Takeda Pharmaceuticals America, Inc. | 0944-0493 | 00944-0493-0100944-0493-02 |
Other NDCs under BLA 101452
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 |
|---|---|---|---|---|
| Flexbuminalbumin human | Albumin human .25 g/mL | SolutionIntravenous | Takeda Pharmaceuticals America, Inc. | 0944-0493 |