Plasma derivative · BLA
Advate (Antihemophilic factor (recombinant)) NDC 0944-3047
Kit · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0944-3047-10 | 00944304710 | 1 BLISTER PACK in 1 CARTON (0944-3047-10) / 1 CONTAINER in 1 BLISTER PACK (0944-3047-12) / 1 KIT in 1 CONTAINER (0944-3047-11) * 5 mL in 1 VIAL, GLASS (0944-2947-01) * 5 mL in 1 VIAL, GLASS (64764-515-50)Marketed from Jul 12, 2012 |
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)
- Advate
- 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 125063
- Marketing start
- Listing expires
- Identifiers
- Product ID 0944-3047_13243ff1-40ce-41c2-964d-279a9ec57595SPL ID 13243ff1-40ce-41c2-964d-279a9ec57595
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
N400944304710followed by a unit qualifier and the quantityPackage 00944-3047-10. 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 0944-3047
- What is NDC 0944-3047?
- 0944-3047 is the product NDC for Advate (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?
- Advate (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 Advate?
- 6 other product NDCs are listed under this name. See all Advate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Advate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Advateantihemophilic factor (recombinant) | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-3051 | 00944-3051-02 |
| Advateantihemophilic factor (recombinant) | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-3052 | 00944-3052-02 |
| Advateantihemophilic factor (recombinant) | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-3053 | 00944-3053-02 |
| Advateantihemophilic factor (recombinant) | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-3054 | 00944-3054-02 |
| Advateantihemophilic factor (recombinant) | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-3046 | 00944-3046-10 |
| Advateantihemophilic factor (recombinant) | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-3045 | 00944-3045-10 |
Other NDCs under BLA 125063
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 |
|---|---|---|---|---|
| Advateantihemophilic factor (recombinant) | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-3045 |
| Advateantihemophilic factor (recombinant) | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-3046 |
| Advateantihemophilic factor (recombinant) | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-3051 |
| Advateantihemophilic factor (recombinant) | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-3052 |
| Advateantihemophilic factor (recombinant) | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-3053 |
| Advateantihemophilic factor (recombinant) | — | Kit | Takeda Pharmaceuticals America, Inc. | 0944-3054 |