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NDC 55150-0351-01 Icatibant 30 mg/3mL Details
Icatibant 30 mg/3mL
Icatibant is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Eugia US LLC. The primary component is ICATIBANT ACETATE.
MedlinePlus Drug Summary
Icatibant is used to treat attacks of hereditary angioedema (HAE; an inherited condition that causes episodes of swelling in the hands, feet, face, airway, or intestines) in adults. Icatibant is in a class of medications called bradykinin B2 receptor antagonists. It works by preventing the binding and therefore, action of bradykinin, a substance responsible for the symptoms of angioedema, in the body.
Related Packages: 55150-0351-01Last Updated: 04/21/2024
MedLinePlus Full Drug Details: Icatibant injection
Product Information
| NDC | 55150-0351 |
|---|---|
| Product ID | 55150-351_56d5047e-3f99-4100-af4f-388870986ced |
| Associated GPIs | |
| GCN Sequence Number | 064564 |
| GCN Sequence Number Description | icatibant acetate SYRINGE 30 MG/3 ML SUBCUT |
| HIC3 | A7M |
| HIC3 Description | BRADYKININ B2 RECEPTOR ANTAGONISTS |
| GCN | 14778 |
| HICL Sequence Number | 035962 |
| HICL Sequence Number Description | ICATIBANT ACETATE |
| Brand/Generic | Generic |
| Proprietary Name | Icatibant |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Icatibant |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 30 |
| Active Ingredient Units | mg/3mL |
| Substance Name | ICATIBANT ACETATE |
| Labeler Name | Eugia US LLC |
| Pharmaceutical Class | Bradykinin B2 Receptor Antagonist [EPC], Bradykinin B2 Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA213521 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55150-0351-01 (55150035101)
| NDC Package Code | 55150-351-01 |
|---|---|
| Billing NDC | 55150035101 |
| Package | 1 SYRINGE, GLASS in 1 CARTON (55150-351-01) / 3 mL in 1 SYRINGE, GLASS |
| Marketing Start Date | 2023-08-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |