Fibryga
- Product NDC
- 68982-347
- 11-digit product format
- 689820347
- Labeler code
- 68982
- Product ID
- 68982-347_6992507e-97be-76ce-a0dc-902d94433f9b
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- Fibrinogen (Human)
- Dosage form
- KIT
- Route
- INTRAVENOUS
- Labeler
- Octapharma USA Inc
- Application
- BLA125612
- Marketing category
- BLA
- Marketing start
- 2017-10-16
- 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
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68982-347-01 | Fibryga | 1 in 1 CARTON | KIT | 1 | | 13 |
| 68982-348-01 | Fibryga | 50 mL in 1 BOTTLE, GLASS | POWDER, FOR SOLUTION | 50 mL | 20 mg in 1mL | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68982-347 | FIBRYGA (FIBRINOGEN (HUMAN)) KIT [OCTAPHARMA USA INC] | 13 | Current NDC, Legacy NDC, 2 package rows | 20240823_007a93f4-d84b-1fa9-51ed-32f6140bf423.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68982-347-01 | 68982034701 | 1 KIT in 1 CARTON (68982-347-01) * 50 mL in 1 BOTTLE, GLASS (68982-348-01) | 1 kit | 2017-10-16 | 0000-00-00 | No | No | Current |
| 68982-348-01 | 68982034801 | 50 mL in 1 BOTTLE, GLASS | 50 ml | | | | | Historical |