Icatibant
- Product NDC
- 55150-351
- 11-digit product format
- 551500351
- Labeler code
- 55150
- Product ID
- 55150-351_ff0f66d4-bb7c-43a6-9475-f8d87f21abb4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icatibant
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Eugia US LLC
- Application
- ANDA213521
- Marketing category
- ANDA
- Marketing start
- 2023-08-14
- 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
- Icatibant
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-351-01 | Icatibant | 3 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 3 | | 2 |
| 55150-351-01 | Icatibant | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 2 |
| 55150-351-03 | Icatibant | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 2 |
| 55150-351-03 | Icatibant | 3 in 1 CARTON | INJECTION, SOLUTION | 3 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-351 | ICATIBANT INJECTION, SOLUTION [EUGIA US LLC] | 2 | Current NDC, 4 package rows | 20240521_56d5047e-3f99-4100-af4f-388870986ced.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55150-351-01 | 55150035101 | 1 SYRINGE, GLASS in 1 CARTON (55150-351-01) / 3 mL in 1 SYRINGE, GLASS | | 2023-08-14 | No | No | Historical |
| 55150-351-03 | 55150035103 | 3 CARTON in 1 CARTON (55150-351-03) / 1 SYRINGE, GLASS in 1 CARTON / 3 mL in 1 SYRINGE, GLASS | 3 carton | 2023-08-14 | No | No | Historical |