ICATIBANT
- Product NDC
- 60505-6214
- 11-digit product format
- 605056214
- Labeler code
- 60505
- Product ID
- 60505-6214_f5893a2f-7a3e-418c-a9e8-b71b78da139d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- icatibant acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Apotex Corp.
- Application
- ANDA212081
- Marketing category
- ANDA
- Marketing start
- 2021-04-15
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-6214 | ICATIBANT (ICATIBANT ACETATE) INJECTION, SOLUTION [APOTEX CORP.] | 6 | Legacy NDC | 20240316_39ecd008-37af-4105-84a0-c0cb98b8d0ec.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60505-6214-1 | 60505621401 | 1 SYRINGE, GLASS in 1 CARTON (60505-6214-1) > 3 mL in 1 SYRINGE, GLASS | 2020-12-18 | 0000-00-00 | No | No | Current |