Icatibant is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Leucadia Pharmaceuticals. The primary component is Icatibant Acetate.
| Product ID | 24201-207_a0808e69-0f38-48de-e053-2a95a90a69d6 |
| NDC | 24201-207 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Icatibant |
| Generic Name | Icatibant |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 2020-03-09 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA211021 |
| Labeler Name | Leucadia Pharmaceuticals |
| Substance Name | ICATIBANT ACETATE |
| Active Ingredient Strength | 30 mg/3mL |
| Pharm Classes | Bradykinin B2 Receptor Antagonist [EPC],Bradykinin B2 Receptor Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-03-09 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA211021 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2020-03-09 |
| Marketing Category | ANDA |
| Application Number | ANDA211021 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2020-03-09 |
| Ingredient | Strength |
|---|---|
| ICATIBANT ACETATE | 30 mg/3mL |
| SPL SET ID: | 94a53361-4eda-4e30-a153-44cd142983dd |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-3066 | Icatibant | Icatibant |
| 24201-207 | Icatibant | icatibant |
| 54092-135 | Icatibant | Icatibant |
| 60505-6214 | ICATIBANT | icatibant acetate |
| 63323-574 | Icatibant | Icatibant |
| 68462-828 | Icatibant | icatibant acetate |
| 69097-664 | ICATIBANT | ICATIBANT |
| 71225-114 | Icatibant | Icatibant |
| 70709-013 | SAJAZIR | ICATIBANT |