Prescription drug · ANDA
Icatibant NDC 69097-664
Icatibant acetate 30 mg/3mL · Injection · Subcutaneous · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-664-34 | 69097066434 | 1 SYRINGE, GLASS in 1 CARTON (69097-664-34) / 3 mL in 1 SYRINGE, GLASSMarketed from Jul 13, 2020 | |
| 69097-664-68 | 69097066468 | 3 SYRINGE, GLASS in 1 CARTON (69097-664-68) / 3 mL in 1 SYRINGE, GLASSMarketed from Jul 13, 2020 |
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)
- Icatibant
- Generic name (nonproprietary)
- icatibant
- Active ingredients
- Icatibant acetate — 30 mg/3mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212446
- Marketing start
- Listing expires
- Other FDA classes
- Bradykinin B2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69097-664_430ca904-a971-4233-a98b-46ca19275dabSPL ID 430ca904-a971-4233-a98b-46ca19275dabSPL set ID ccbb5e50-ce56-4898-aa1a-f1c1f3d312f6RxCUI 1148141UNII 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
N469097066434followed by a unit qualifier and the quantityPackage 69097-0664-34. 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)
Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Icatibant injection 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.
Other NDCs under ANDA 212446
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 |
|---|---|---|---|---|
| Sajaziricatibant | Icatibant acetate 30 mg/3mL | InjectionSubcutaneous | Cycle Pharmaceuticals Ltd-Uk | 70709-013 |