Icatibant
- Product NDC
- 71225-114
- 11-digit product format
- 712250114
- Labeler code
- 71225
- Product ID
- 71225-114_dceae0e8-5b3d-4031-a0dc-9c89eb2d0c30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Icatibant
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Slayback Pharma LLC
- Application
- ANDA211501
- Marketing category
- ANDA
- Marketing start
- 2021-01-28
- 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
- 2022-12-31
- 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 |
|---|
| 71225-114-01 | 71225011401 | 1 SYRINGE, GLASS in 1 CARTON (71225-114-01) > 3 mL in 1 SYRINGE, GLASS | 2021-01-28 | 0000-00-00 | No | No | Current |
| 71225-114-02 | 71225011402 | 3 SYRINGE, GLASS in 1 CARTON (71225-114-02) > 3 mL in 1 SYRINGE, GLASS | 2021-01-28 | 0000-00-00 | No | No | Current |