Fibryga
- Product NDC
- 68982-349
- 11-digit product format
- 689820349
- Labeler code
- 68982
- Product ID
- 68982-349_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
- 2024-12-20
- 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 |
|---|
| 68982-349-01 | Fibryga | 1 in 1 CARTON | POWDER, FOR SOLUTION | 1 | | 4 |
| 68982-349-81 | Fibryga | 50 mL in 1 BOTTLE, GLASS | POWDER, FOR SOLUTION | 50 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68982-349 | FIBRYGA (FIBRINOGEN (HUMAN)) POWDER, FOR SOLUTION [OCTAPHARMA USA INC] | 1 | Current NDC, 2 package rows | 20250103_e3422d2a-2cb6-6f49-0be7-cb960b3d5bd5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68982-349-01 | 68982034901 | 1 BOTTLE, GLASS in 1 CARTON (68982-349-01) / 50 mL in 1 BOTTLE, GLASS (68982-349-81) | | 2024-12-20 | No | No | Current |
| 68982-349-81 | 68982034981 | 50 mL in 1 BOTTLE, GLASS | 50 ml | | | | Historical |