Firazyr is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Shire Us Manufacturing Inc.. The primary component is Icatibant Acetate.
Product ID | 54092-702_120b58c8-8b37-4932-a1ec-8cc06daa3819 |
NDC | 54092-702 |
Product Type | Human Prescription Drug |
Proprietary Name | Firazyr |
Generic Name | Icatibant Acetate |
Dosage Form | Injection, Solution |
Route of Administration | SUBCUTANEOUS |
Marketing Start Date | 2011-08-25 |
Marketing Category | NDA / NDA |
Application Number | NDA022150 |
Labeler Name | Shire US Manufacturing Inc. |
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 | 2011-08-25 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA022150 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2011-08-25 |
Marketing Category | NDA |
Application Number | NDA022150 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2011-08-25 |
Marketing Category | NDA |
Application Number | NDA022150 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2011-08-25 |
Ingredient | Strength |
---|---|
ICATIBANT ACETATE | 30 mg/3mL |
SPL SET ID: | ed6657ca-ab68-477a-9968-e12dc928b540 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
54092-135 | Firazyr | icatibant acetate |
54092-702 | Firazyr | icatibant acetate |
60505-6214 | ICATIBANT | icatibant acetate |
68462-828 | Icatibant | icatibant acetate |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FIRAZYR 78876453 3329286 Live/Registered |
Shire Orphan Therapies GmbH 2006-05-04 |