Plasma derivative · BLA
Zemaira (Alpha-1-proteinase inhibitor human) NDC 0053-7201
Kit · CSL Behring LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0053-7201-02 | 0005372010200053720102 | 1 KIT in 1 CARTON (0053-7201-02) * 20 mL in 1 VIAL, SINGLE-DOSE (0053-7211-01) * 20 mL in 1 VIAL, SINGLE-DOSE (0053-7653-20)Marketed from Jul 8, 2003 |
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 LLCNDC labeler code 0053
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125078
- Marketing start
- Listing expires
- Identifiers
- Product ID 0053-7201_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
N400053720102followed by a unit qualifier and the quantityPackage 00053-7201-02. 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 0053-7201
- What is NDC 0053-7201?
- 0053-7201 is the product NDC for Zemaira (alpha-1-proteinase inhibitor human) kit, listed with the FDA by CSL Behring LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zemaira (Alpha-1-proteinase inhibitor human).
- Who is the labeler?
- CSL Behring LLC, NDC labeler code 0053. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zemaira?
- 5 other product NDCs are listed under this name. See all Zemaira NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zemaira products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zemairaalpha-1-proteinase inhibitor human kit | — | KitIntravenous | Fisher Clinical Services Inc. | 57516-110 | 57516-0110-02 |
| Zemairaalpha-1-proteinase inhibitor human kit | — | KitIntravenous | Fisher Clinical Services Inc. | 57516-113 | 57516-0113-02 |
| Zemairaalpha-1-proteinase inhibitor human kit | — | KitIntravenous | Fisher Clinical Services Inc. | 57516-101 | 57516-0101-02 |
| Zemaira.alpha.1-proteinase inhibitor human | — | Kit | CSL Behring LLC | 0053-7202 | 00053-7202-02 |
| Zemaira.alpha.1-proteinase inhibitor human | — | Kit | CSL Behring LLC | 0053-7203 | 00053-7203-02 |
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 |
|---|---|---|---|---|
| Zemaira.alpha.1-proteinase inhibitor human | — | Kit | CSL Behring LLC | 0053-7202 |
| Zemaira.alpha.1-proteinase inhibitor human | — | Kit | CSL Behring LLC | 0053-7203 |
| 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 |