Prescription drug · NDA
Firazyr (icatibant acetate) NDC 54092-702
Icatibant acetate 30 mg/3mL · Injection, Solution · Subcutaneous · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54092-702-01 | 54092070201 | 1 SYRINGE, GLASS in 1 CARTON (54092-702-01) / 3 mL in 1 SYRINGE, GLASSMarketed from Aug 25, 2011 | |
| 54092-702-02 | 54092070202 | 1 SYRINGE, GLASS in 1 CARTON (54092-702-02) / 3 mL in 1 SYRINGE, GLASSMarketed from Aug 25, 2011 | |
| 54092-702-03 | 54092070203 | 3 SYRINGE, GLASS in 1 CARTON (54092-702-03) / 3 mL in 1 SYRINGE, GLASSMarketed from Aug 25, 2011 |
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)
- Firazyr
- Generic name (nonproprietary)
- icatibant acetate
- Active ingredients
- Icatibant acetate — 30 mg/3mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022150
- Marketing start
- Listing expires
- Other FDA classes
- Bradykinin B2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 54092-702_19b83a10-9f38-4d0d-ae46-0f5b28168873SPL ID 19b83a10-9f38-4d0d-ae46-0f5b28168873SPL set ID ed6657ca-ab68-477a-9968-e12dc928b540RxCUI 1148141, 1148145UNII 325O8467XK
- Pharmacologic class
- Bradykinin B2 Receptor Antagonist
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
N454092070201followed by a unit qualifier and the quantityPackage 54092-0702-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
FIRAZYR ® (icatibant) is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. FIRAZYR is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.