Plasma derivative · BLA
Recombinate (Antihemophilic factor recombinant) NDC 0944-2845
Kit · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0944-2845-10 | 00944284510 | 1 KIT in 1 CARTON (0944-2845-10) * 10 mL in 1 VIAL, GLASS (0944-2835-01) * 5 mL in 1 VIAL, GLASS (64764-515-50)Marketed from Mar 15, 2010 |
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)
- Recombinate
- Generic name (nonproprietary)
- antihemophilic factor recombinant
- Dosage form
- Kit
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 0944
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103375
- Marketing start
- Listing expires
- Identifiers
- Product ID 0944-2845_217500ff-5413-48b5-adab-ac72eb2dc128SPL ID 217500ff-5413-48b5-adab-ac72eb2dc128
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.
- NDC on a medical claim
N400944284510followed by a unit qualifier and the quantityPackage 00944-2845-10. 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 0944-2845
- What is NDC 0944-2845?
- 0944-2845 is the product NDC for Recombinate (antihemophilic factor recombinant) kit, 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?
- Recombinate (Antihemophilic factor recombinant).
- 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 Recombinate?
- 4 other product NDCs are listed under this name. See all Recombinate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Recombinate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Recombinateantihemophilic factor recombinant | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-2844 | 00944-2844-10 |
| Recombinateantihemophilic factor recombinant | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-2841 | 00944-2841-10 |
| Recombinateantihemophilic factor recombinant | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-2842 | 00944-2842-10 |
| Recombinateantihemophilic factor recombinant | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-2843 | 00944-2843-10 |
Other NDCs under BLA 103375
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 |
|---|---|---|---|---|
| Recombinateantihemophilic factor recombinant | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-2841 |
| Recombinateantihemophilic factor recombinant | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-2842 |
| Recombinateantihemophilic factor recombinant | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-2843 |
| Recombinateantihemophilic factor recombinant | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-2844 |