DigiFab
- Product NDC
- 87131-120
- 11-digit product format
- 871310120
- Labeler code
- 87131
- Product ID
- 87131-120_4f52f8aa-b32a-794d-e063-6394a90a70b8
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- ovine digoxin immune fab
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Salvagenix Inc.
- Application
- BLA103910
- Marketing category
- BLA
- Marketing start
- 2026-03-20
- Substance
- OVINE DIGOXIN IMMUNE FAB
- Active strength
- 40 mg/1
- Pharmacologic classes
- Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DigiFab
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OVINE DIGOXIN IMMUNE FAB | 40 mg/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 87131-120-11 | DigiFab | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
| 87131-120-12 | DigiFab | 1 in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 103910 | Digifab | Digoxin Immune Fab (Ovine) | 351(a) | Rx | 2026-06-01 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 87131-120-11 | 87131012011 | 1 VIAL, GLASS in 1 CARTON (87131-120-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (87131-120-12) | 2026-03-20 | No | No | Current |
| 87131-120-12 | 87131012012 | 1 in 1 VIAL, GLASS | | | | Historical |