Fibryga
- Product NDC
- 68982-350
- 11-digit product format
- 689820350
- Labeler code
- 68982
- Product ID
- 68982-350_46907c4a-5b69-fff9-8ecc-32c6ed0ed480
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- Fibrinogen (Human)
- Dosage form
- POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Octapharma USA Inc
- Application
- BLA125612
- Marketing category
- BLA
- Marketing start
- 2025-06-23
- Substance
- FIBRINOGEN HUMAN
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fibryga
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FIBRINOGEN HUMAN | 20 mg/mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68982-350-01 | Fibryga | 1 in 1 CARTON | POWDER, FOR SOLUTION | 1 | | 4 |
| 68982-350-81 | Fibryga | 100 mL in 1 BOTTLE, GLASS | POWDER, FOR SOLUTION | 100 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68982-350-01 | 68982035001 | 1 BOTTLE, GLASS in 1 CARTON (68982-350-01) / 100 mL in 1 BOTTLE, GLASS (68982-350-81) | | 2025-06-23 | No | No | Historical |
| 68982-350-81 | 68982035081 | 100 mL in 1 BOTTLE, GLASS | 100 ml | | | | Historical |