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NDC 50633-0120-11 DigiFab 40 mg/1 Details
DigiFab 40 mg/1
DigiFab is a INTRAVENOUS INJECTION, POWDER, FOR SOLUTION in the PLASMA DERIVATIVE category. It is labeled and distributed by BTG International Inc.. The primary component is OVINE DIGOXIN IMMUNE FAB.
Product Information
| NDC | 50633-0120 |
|---|---|
| Product ID | 50633-120_264eda52-fe4a-4fad-9a07-c3b94872bf24 |
| Associated GPIs | 93000025102120 |
| GCN Sequence Number | 049773 |
| GCN Sequence Number Description | digoxin immune fab VIAL 40 MG INTRAVEN |
| HIC3 | C8E |
| HIC3 Description | ANTIDOTES,MISCELLANEOUS |
| GCN | 15446 |
| HICL Sequence Number | 001118 |
| HICL Sequence Number Description | DIGOXIN IMMUNE FAB |
| Brand/Generic | Brand |
| Proprietary Name | DigiFab |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ovine digoxin immune fab |
| Product Type | PLASMA DERIVATIVE |
| Dosage Form | INJECTION, POWDER, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | mg/1 |
| Substance Name | OVINE DIGOXIN IMMUNE FAB |
| Labeler Name | BTG International Inc. |
| Pharmaceutical Class | Cardiac Glycoside [EPC], Cardiac Glycosides [CS] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA103910 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50633-0120-11 (50633012011)
| NDC Package Code | 50633-120-11 |
|---|---|
| Billing NDC | 50633012011 |
| Package | 1 VIAL, GLASS in 1 CARTON (50633-120-11) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (50633-120-12) |
| Marketing Start Date | 2001-08-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |