Icatibant
- Product NDC
- 63323-574
- 11-digit product format
- 633230574
- Labeler code
- 63323
- Product ID
- 63323-574_d1c9afa7-c4ac-4739-85f1-2ae82440210c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icatibant
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA208317
- Marketing category
- ANDA
- Marketing start
- 2020-11-15
- Substance
- ICATIBANT ACETATE
- Active strength
- 10 mg/mL
- 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 | 10 mg/mL |
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 |
|---|
| 63323-574-01 | Icatibant | 3 mL in 1 SYRINGE | INJECTION, SOLUTION | 3 | | 4 |
| 63323-574-86 | Icatibant | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
| 63323-574-93 | Icatibant | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
| 63323-574-93 | Icatibant | 3 in 1 BOX | INJECTION, SOLUTION | 3 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-574 | ICATIBANT (ICATIBANT) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240106_52c12c15-c00b-4efc-952d-1425c907706a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-574-01 | 63323057401 | 3 mL in 1 SYRINGE | 3 ml | | | | | Historical |
| 63323-574-86 | 63323057486 | 1 SYRINGE in 1 CARTON (63323-574-86) / 3 mL in 1 SYRINGE (63323-574-01) | 1 syringe | 2020-11-15 | 0000-00-00 | No | No | Current |
| 63323-574-93 | 63323057493 | 3 CARTON in 1 BOX (63323-574-93) / 1 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE | 3 carton | 2020-11-15 | 0000-00-00 | No | No | Current |