Plasma derivative · BLA
HAEGARDA C1 Esterase Inhibitor Subcutaneous (Human) (Human c1-esterase inhibitor) NDC 63833-829
Kit · CSL Behring GmbH
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63833-829-02 | 6383308290263833082902 | 1 KIT in 1 CARTON (63833-829-02) * 5.6 mL in 1 VIAL, SINGLE-USE (63833-839-01) * 5.6 mL in 1 VIAL, SINGLE-USE (63833-765-19)Marketed from Jun 22, 2017 |
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)
- HAEGARDA C1 Esterase Inhibitor Subcutaneous (Human)Suffix: C1 Esterase Inhibitor Subcutaneous (Human)
- Generic name (nonproprietary)
- human c1-esterase inhibitor
- Dosage form
- Kit
- Labeler
- CSL Behring GmbHNDC labeler code 63833
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125606
- Marketing start
- Listing expires
- Identifiers
- Product ID 63833-829_c53fd34d-f366-4ee5-bbea-88201bf6b7c8SPL ID c53fd34d-f366-4ee5-bbea-88201bf6b7c8
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
N463833082902followed by a unit qualifier and the quantityPackage 63833-0829-02. 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 63833-829
- What is NDC 63833-829?
- 63833-829 is the product NDC for HAEGARDA C1 Esterase Inhibitor Subcutaneous (Human) kit, listed with the FDA by CSL Behring GmbH. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- HAEGARDA C1 Esterase Inhibitor Subcutaneous (Human) (Human c1-esterase inhibitor).
- Who is the labeler?
- CSL Behring GmbH, NDC labeler code 63833. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for HAEGARDA C1 Esterase Inhibitor Subcutaneous (Human)?
- 1 other product NDC are listed under this name. See all HAEGARDA C1 Esterase Inhibitor Subcutaneous (Human) NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other HAEGARDA C1 Esterase Inhibitor Subcutaneous (Human) products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| HAEGARDA C1 Esterase Inhibitor Subcutaneous (Human)human c1-esterase inhibitor | — | Kit | CSL Behring GmbH | 63833-828 | 63833-0828-02 |
Other NDCs under BLA 125606
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 |
|---|---|---|---|---|
| HAEGARDA C1 Esterase Inhibitor Subcutaneous (Human)human c1-esterase inhibitor | — | Kit | CSL Behring GmbH | 63833-828 |