Plasma derivative · BLA
AFSTYLA Antihemophilic Factor (Recombinant), Single Chain (Antihemophilic factor, human recombinant) NDC 69911-478
Kit · CSL Behring Lengnau AG
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69911-478-02 | 6991104780269911047802 | 1 KIT in 1 CARTON (69911-478-02) * 5 mL in 1 VIAL, SINGLE-USE (69911-765-84) * 5 mL in 1 VIAL, SINGLE-USE (69911-488-01)Marketed from May 25, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- AFSTYLA Antihemophilic Factor (Recombinant), Single ChainSuffix: Antihemophilic Factor (Recombinant), Single Chain
- Generic name (nonproprietary)
- antihemophilic factor, human recombinant
- Dosage form
- Kit
- Labeler
- CSL Behring Lengnau AGNDC labeler code 69911
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125591
- Marketing start
- Listing expires
- Identifiers
- Product ID 69911-478_757ccd2f-85b7-440f-905f-b999e2d1dd4bSPL ID 757ccd2f-85b7-440f-905f-b999e2d1dd4b
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
N469911047802followed by a unit qualifier and the quantityPackage 69911-0478-02. 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.
About NDC 69911-478
- What is NDC 69911-478?
- 69911-478 is the product NDC for AFSTYLA Antihemophilic Factor (Recombinant), Single Chain kit, listed with the FDA by CSL Behring Lengnau AG. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- AFSTYLA Antihemophilic Factor (Recombinant), Single Chain (Antihemophilic factor, Human recombinant).
- Who is the labeler?
- CSL Behring Lengnau AG, NDC labeler code 69911. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for AFSTYLA Antihemophilic Factor (Recombinant), Single Chain?
- 6 other product NDCs are listed under this name. See all AFSTYLA Antihemophilic Factor (Recombinant), Single Chain NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other AFSTYLA Antihemophilic Factor (Recombinant), Single Chain products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| AFSTYLA Antihemophilic Factor (Recombinant), Single Chainantihemophilic factor, human recombinant | — | Kit | CSL Behring Lengnau AG | 69911-480 | 69911-0480-02 |
| AFSTYLA Antihemophilic Factor (Recombinant), Single Chainantihemophilic factor, human recombinant | — | Kit | CSL Behring Lengnau AG | 69911-481 | 69911-0481-02 |
| AFSTYLA Antihemophilic Factor (Recombinant), Single Chainantihemophilic factor, human recombinant | — | Kit | CSL Behring Lengnau AG | 69911-474 | 69911-0474-02 |
| AFSTYLA Antihemophilic Factor (Recombinant), Single Chainantihemophilic factor, human recombinant | — | Kit | CSL Behring Lengnau AG | 69911-475 | 69911-0475-02 |
| AFSTYLA Antihemophilic Factor (Recombinant), Single Chainantihemophilic factor, human recombinant | — | Kit | CSL Behring Lengnau AG | 69911-476 | 69911-0476-02 |
| AFSTYLA Antihemophilic Factor (Recombinant), Single Chainantihemophilic factor, human recombinant | — | Kit | CSL Behring Lengnau AG | 69911-477 | 69911-0477-02 |
Other NDCs under BLA 125591
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 |
|---|---|---|---|---|
| AFSTYLA Antihemophilic Factor (Recombinant), Single Chainantihemophilic factor, human recombinant | — | Kit | CSL Behring Lengnau AG | 69911-474 |
| AFSTYLA Antihemophilic Factor (Recombinant), Single Chainantihemophilic factor, human recombinant | — | Kit | CSL Behring Lengnau AG | 69911-475 |
| AFSTYLA Antihemophilic Factor (Recombinant), Single Chainantihemophilic factor, human recombinant | — | Kit | CSL Behring Lengnau AG | 69911-476 |
| AFSTYLA Antihemophilic Factor (Recombinant), Single Chainantihemophilic factor, human recombinant | — | Kit | CSL Behring Lengnau AG | 69911-477 |
| AFSTYLA Antihemophilic Factor (Recombinant), Single Chainantihemophilic factor, human recombinant | — | Kit | CSL Behring Lengnau AG | 69911-480 |
| AFSTYLA Antihemophilic Factor (Recombinant), Single Chainantihemophilic factor, human recombinant | — | Kit | CSL Behring Lengnau AG | 69911-481 |