Prescription drug · ANDA
Icatibant NDC 0093-3066
Icatibant acetate 10 mg/mL · Injection, Solution · Subcutaneous · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-3066-34 | 00093306634 | 1 SYRINGE in 1 CARTON (0093-3066-34) / 3 mL in 1 SYRINGEMarketed from Jul 15, 2019 | |
| 0093-3066-93 | 00093306693 | 3 CARTON in 1 BOX (0093-3066-93) / 1 SYRINGE in 1 CARTON (0093-3066-19) / 3 mL in 1 SYRINGEMarketed from Jul 15, 2019 |
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)
- Icatibant
- Generic name (nonproprietary)
- icatibant
- Active ingredients
- Icatibant acetate — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210118
- Marketing start
- Listing expires
- Other FDA classes
- Bradykinin B2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0093-3066_56c3b3d7-5c66-422c-a72d-30b3599d71dbSPL ID 56c3b3d7-5c66-422c-a72d-30b3599d71dbSPL set ID 402a20e0-d1e2-4a24-ae1d-f2ff6d8fa7b3RxCUI 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
N400093306634followed by a unit qualifier and the quantityPackage 00093-3066-34. 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.