Icatibant
- Product NDC
- 46708-654
- 11-digit product format
- 467080654
- Labeler code
- 46708
- Product ID
- 46708-654_8c149392-d281-4311-880f-3be2b4752f40
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icatibant
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA213773
- Marketing category
- ANDA
- Marketing start
- 2024-06-14
- 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 |
|---|
| 46708-654-03 | Icatibant | 3 mL in 1 SYRINGE, GLASS | INJECTION | 3 | | 1 |
| 46708-654-03 | Icatibant | 1 in 1 CARTON | INJECTION | 1 | | 1 |
| 46708-654-09 | Icatibant | 3 mL in 1 SYRINGE, GLASS | INJECTION | 3 | | 1 |
| 46708-654-09 | Icatibant | 3 in 1 CARTON | INJECTION | 3 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-654-03 | 46708065403 | 1 SYRINGE, GLASS in 1 CARTON (46708-654-03) / 3 mL in 1 SYRINGE, GLASS | 2024-06-14 | No | No | Historical |
| 46708-654-09 | 46708065409 | 3 SYRINGE, GLASS in 1 CARTON (46708-654-09) / 3 mL in 1 SYRINGE, GLASS | 2024-06-14 | No | No | Historical |