Cinryze (human c1-esterase inhibitor) NDC 42227-081

NDC codes

FDA NDC Directory

Product NDC (as listed)42227-081Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42227-0081Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
42227-081-01	42227008101	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.
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 125267
Marketing start: Dec 1, 2008
Listing expires: Dec 31, 2026
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.

How CPT relates to drug billing

NDC on a medical claim

N442227008101 followed by a unit qualifier and the quantity

Package 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.

Other NDCs under BLA 125267

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 125267
Product	Strength	Form · route	Labeler	Product NDC
Cinryzehuman c1-esterase inhibitor	—	Kit	Takeda Pharmaceuticals America, Inc.	42227-083