NDC 54092-702
Firazyr
Icatibant Acetate
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 |
Packaging
NDC 54092-702-01
1 SYRINGE, GLASS in 1 CARTON (54092-702-01) > 3 mL in 1 SYRINGE, GLASS
| Marketing Start Date | 2011-08-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 54092-702-02 [54092070202]
Firazyr INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA022150 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-08-25 |
NDC 54092-702-03 [54092070203]
Firazyr INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA022150 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-08-25 |
NDC 54092-702-01 [54092070201]
Firazyr INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA022150 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-08-25 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ICATIBANT ACETATE | 30 mg/3mL |
OpenFDA Data
| SPL SET ID: | ed6657ca-ab68-477a-9968-e12dc928b540 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Bradykinin B2 Receptor Antagonist [EPC]
- Bradykinin B2 Receptor Antagonists [MoA]
NDC Crossover Matching brand name "Firazyr" or generic name "Icatibant Acetate"
| 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 |
Trademark Results [Firazyr]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIRAZYR 78876453 3329286 Live/Registered |
Shire Orphan Therapies GmbH 2006-05-04 |
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