Plasma derivative · BLA
Zemaira (.alpha.1-proteinase inhibitor human) NDC 0053-7202
Kit · CSL Behring LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0053-7202-02 | 00053720202 | 1 KIT in 1 CARTON (0053-7202-02) * 76 mL in 1 VIAL, SINGLE-USE (0053-7212-01) * 76 mL in 1 VIAL, SINGLE-USE (0053-7653-80)Marketed from Apr 24, 2019 |
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)
- Zemaira
- Generic name (nonproprietary)
- .alpha.1-proteinase inhibitor human
- Dosage form
- Kit
- Labeler
- CSL Behring LLC
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125078
- Marketing start
- Listing expires
- Identifiers
- Product ID 0053-7202_a60040d6-46ed-4a3b-af7e-528a65b7fca7SPL ID a60040d6-46ed-4a3b-af7e-528a65b7fca7
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
N400053720202followed by a unit qualifier and the quantityPackage 00053-7202-02. 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 125078
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 |
|---|---|---|---|---|
| Zemairaalpha-1-proteinase inhibitor human kit | — | KitIntravenous | Fisher Clinical Services Inc. | 57516-101 |
| Zemairaalpha-1-proteinase inhibitor human kit | — | KitIntravenous | Fisher Clinical Services Inc. | 57516-110 |
| Zemairaalpha-1-proteinase inhibitor human kit | — | KitIntravenous | Fisher Clinical Services Inc. | 57516-113 |
| Zemaira.alpha.1-proteinase inhibitor human | — | Kit | CSL Behring LLC | 0053-7203 |
| Zemairaalpha-1-proteinase inhibitor human | — | Kit | CSL Behring LLC | 0053-7201 |