Firazyr
- Product NDC
- 54092-702
- 11-digit product format
- 540920702
- Labeler code
- 54092
- Product ID
- 54092-702_19b83a10-9f38-4d0d-ae46-0f5b28168873
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- icatibant acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- NDA022150
- Marketing category
- NDA
- Marketing start
- 2011-08-25
- Substance
- ICATIBANT ACETATE
- Active strength
- 30 mg/3mL
- Pharmacologic classes
- Bradykinin B2 Receptor Antagonist [EPC], Bradykinin B2 Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Firazyr
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ICATIBANT ACETATE | 30 mg/3mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 325O8467XK |
| Rxcui | 1148141, 1148145 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54092-702-01 | Firazyr | 3 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 3 | | 19 |
| 54092-702-01 | Firazyr | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 19 |
| 54092-702-02 | Firazyr | 3 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 3 | | 19 |
| 54092-702-02 | Firazyr | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 19 |
| 54092-702-03 | Firazyr | 3 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 3 | | 19 |
| 54092-702-03 | Firazyr | 3 in 1 CARTON | INJECTION, SOLUTION | 3 | | 19 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54092-702 | FIRAZYR (ICATIBANT ACETATE) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 18 | Current NDC, Legacy NDC, 6 package rows | 20240131_ed6657ca-ab68-477a-9968-e12dc928b540.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54092-702-01 | 54092070201 | 1 SYRINGE, GLASS in 1 CARTON (54092-702-01) / 3 mL in 1 SYRINGE, GLASS | 2011-08-25 | 0000-00-00 | No | No | Current |
| 54092-702-02 | 54092070202 | 1 SYRINGE, GLASS in 1 CARTON (54092-702-02) / 3 mL in 1 SYRINGE, GLASS | 2011-08-25 | 0000-00-00 | No | No | Current |
| 54092-702-03 | 54092070203 | 3 SYRINGE, GLASS in 1 CARTON (54092-702-03) / 3 mL in 1 SYRINGE, GLASS | 2011-08-25 | 0000-00-00 | No | No | Current |