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 |
|---|---|
| OVINE DIGOXIN IMMUNE FAB | 40 mg/1 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 20d84de3-cb46-44c4-9211-63e833fa2688 | Product name | 2 | 20221214 |
| 4d74103a-bb9b-9034-fbc8-dac635e6e729 | Product name | 3 | 20221117 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 5c3aa978-6f46-c7ca-2a83-b57385976bee | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 87131-120-11 | EA - Each | 87131-120 | eabee163-25a4-4a30-a65d-5e970cbba66d | 1 | 2026-04-20 |
| 87131-120-12 | EA - Each | 87131-120 | 3883efc6-a996-40e0-8b6f-491b0548f660 | 1 | 2026-04-20 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 404702 | DigiFab 40 MG Injection | PSN | 49ee0505-77a0-1ff4-e063-6294a90a410e | 4 |
| 349326 | digoxin immune fab (ovine) 40 MG Injection | PSN | 49ee0505-77a0-1ff4-e063-6294a90a410e | 4 |
| 404702 | ovine digoxin immune fab 40 MG Injection [DigiFab] | SBD | 49ee0505-77a0-1ff4-e063-6294a90a410e | 4 |
| 349326 | ovine digoxin immune fab 40 MG Injection | SCD | 49ee0505-77a0-1ff4-e063-6294a90a410e | 4 |
| 404702 | DigiFab 40 MG Injection | SY | 49ee0505-77a0-1ff4-e063-6294a90a410e | 4 |
Packages#
| 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 | Historical |
| 87131-120-12 | 87131012012 | 1 in 1 VIAL, GLASS | Historical |