FESILTY
- Product NDC
- 13533-502
- 11-digit product format
- 135330502
- Labeler code
- 13533
- Product ID
- 13533-502_0a02a77c-7d42-48f2-b404-e1e57bd37beb
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- fibrinogen, human-chmt
- Dosage form
- KIT
- Labeler
- Grifols USA LLC
- Application
- BLA125833
- Marketing category
- BLA
- Marketing start
- 2025-12-16
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FESILTY
- Listing expiration
- 2027-12-31
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13533-502-01 | FESILTY | 1 in 1 CARTON | KIT | 1 | | 2 |
| 13533-503-02 | FESILTY | 50 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 1 mL | 20 mg in 1mL | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 13533-502-01 | 13533050201 | 1 KIT in 1 CARTON (13533-502-01) * 50 mL in 1 VIAL, GLASS (13533-503-02) * 50 mL in 1 VIAL, GLASS (13533-200-50) | 1 kit | 2025-12-16 | No | No | Current |
| 13533-503-02 | 13533050302 | 50 mL in 1 VIAL, GLASS | 50 ml | | | | Historical |