Icatibant
- Product NDC
- 54092-135
- 11-digit product format
- 540920135
- Labeler code
- 54092
- Product ID
- 54092-135_e2a326de-81cc-4931-824d-53ffc12582fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icatibant
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- NDA022150
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-07-30
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54092-135-01 | 54092013501 | 1 SYRINGE, GLASS in 1 CARTON (54092-135-01) > 3 mL in 1 SYRINGE, GLASS | 2019-07-30 | 0000-00-00 | No | No | Current |
| 54092-135-02 | 54092013502 | 3 SYRINGE, GLASS in 1 CARTON (54092-135-02) > 3 mL in 1 SYRINGE, GLASS | 2019-07-30 | 0000-00-00 | No | No | Current |