Plasma derivative · BLA
Cinryze (Human c1-esterase inhibitor) NDC 42227-081
Human c1-esterase inhibitor 500 [iU]/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42227-081-01 | 4222700810142227008101 | 5 mL in 1 VIAL, SINGLE-USE (42227-081-01)Marketed from Dec 1, 2008 |
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)
- Cinryze
- Generic name (nonproprietary)
- human c1-esterase inhibitor
- Active ingredients
- Human c1-esterase inhibitor — 500 [iU]/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 42227
- Product type
- Plasma derivative
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125267
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Vascular Permeability (Physiologic effect)Kallikrein Inhibitors (Mechanism)
- Identifiers
- Product ID 42227-081_421ea216-278f-4ca8-ae5d-5dafe85658a0SPL ID 421ea216-278f-4ca8-ae5d-5dafe85658a0
- Pharmacologic class
- Human C1 Esterase Inhibitor
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N442227008101followed by a unit qualifier and the quantityPackage 42227-0081-01. 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 42227-081
- What is NDC 42227-081?
- 42227-081 is the product NDC for Cinryze (human c1-esterase inhibitor), Human c1-esterase inhibitor 500 [iU]/5mL injection, powder, lyophilized, for solution, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cinryze (Human c1-esterase inhibitor).
- What is the active ingredient?
- Human c1-esterase inhibitor.
- Who is the labeler?
- Takeda Pharmaceuticals America, Inc., NDC labeler code 42227. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cinryze?
- 1 other product NDC are listed under this name. See all Cinryze NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cinryze products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cinryzehuman c1-esterase inhibitor | — | Kit | Takeda Pharmaceuticals America, Inc. | 42227-083 | 42227-0083-01 |
Other NDCs under BLA 125267
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 |
|---|---|---|---|---|
| Cinryzehuman c1-esterase inhibitor | — | Kit | Takeda Pharmaceuticals America, Inc. | 42227-083 |