Icatibant
- Product NDC
- 68462-828
- 11-digit product format
- 684620828
- Labeler code
- 68462
- Product ID
- 68462-828_8d6e2f8a-884d-48eb-b95f-f74d5ddd6c65
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- icatibant acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- GLENMARK PHARMACEUTICALS INC., USA
- Application
- ANDA213222
- Marketing category
- ANDA
- Marketing start
- 2021-05-21
- 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68462-828-15 | 68462082815 | 1 SYRINGE, GLASS in 1 CARTON (68462-828-15) > 3 mL in 1 SYRINGE, GLASS | 2021-05-21 | 0000-00-00 | No | No | Current |
| 68462-828-46 | 68462082846 | 3 SYRINGE, GLASS in 1 CARTON (68462-828-46) > 3 mL in 1 SYRINGE, GLASS | 2021-05-21 | 0000-00-00 | No | No | Current |