Plasma derivative · BLA
Advate (antihemophilic factor (recombinant)) NDC 0944-3053
Kit · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0944-3053-02 | 00944305302 | 1 BLISTER PACK in 1 CARTON (0944-3053-02) / 1 CONTAINER in 1 BLISTER PACK (0944-3053-04) / 1 KIT in 1 CONTAINER (0944-3053-03) * 5 mL in 1 VIAL, GLASS (0944-2943-02) * 2 mL in 1 VIAL, GLASS (64764-514-02)Marketed from Dec 15, 2011 |
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
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125063
- Marketing start
- Listing expires
- Identifiers
- Product ID 0944-3053_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
N400944305302followed by a unit qualifier and the quantityPackage 00944-3053-02. 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 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. | 0944-3047 |
| 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. | 0944-3054 |