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NDC 50633-0110-12 CroFab 1; 1; 1; 1 g/1; g/1; g/1; g/1 Details
CroFab 1; 1; 1; 1 g/1; g/1; g/1; g/1
CroFab is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the PLASMA DERIVATIVE category. It is labeled and distributed by BTG International Inc.. The primary component is AGKISTRODON PISCIVORUS IMMUNE FAB ANTIVENIN (OVINE); CROTALUS ADAMANTEUS IMMUNE FAB ANTIVENIN (OVINE); CROTALUS ATROX IMMUNE FAB ANTIVENIN (OVINE); CROTALUS SCUTULATUS IMMUNE FAB ANTIVENIN (OVINE).
Product Information
| NDC | 50633-0110 |
|---|---|
| Product ID | 50633-110_ead6b85f-cb43-49cf-8024-95be6aec87d1 |
| Associated GPIs | 19200021002120 |
| GCN Sequence Number | 048317 |
| GCN Sequence Number Description | antivenin,crotalidae Fab(ovin) VIAL INJECTION |
| HIC3 | W7S |
| HIC3 Description | ANTIVENINS |
| GCN | 47613 |
| HICL Sequence Number | 022818 |
| HICL Sequence Number Description | ANTIVENIN,CROTALIDAE FAB(OVIN) |
| Brand/Generic | Brand |
| Proprietary Name | CroFab |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ovine crotalidae venoms immune fab |
| Product Type | PLASMA DERIVATIVE |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 1; 1; 1; 1 |
| Active Ingredient Units | g/1; g/1; g/1; g/1 |
| Substance Name | AGKISTRODON PISCIVORUS IMMUNE FAB ANTIVENIN (OVINE); CROTALUS ADAMANTEUS IMMUNE FAB ANTIVENIN (OVINE); CROTALUS ATROX IMMUNE FAB ANTIVENIN (OVINE); CROTALUS SCUTULATUS IMMUNE FAB ANTIVENIN (OVINE) |
| Labeler Name | BTG International Inc. |
| Pharmaceutical Class | Antivenin [EPC], Antivenin [EPC], Antivenin [EPC], Antivenin [EPC], Antivenins [Chemical/Ingredient], Antivenins [Chemical/Ingredient], Antivenins [Chemical/Ingredient], Antivenins [Chemical/Ingredient], Passively Acquired Immunity [PE], Passively Acquire |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA103788 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50633-0110-12 (50633011012)
| NDC Package Code | 50633-110-12 |
|---|---|
| Billing NDC | 50633011012 |
| Package | 2 VIAL, GLASS in 1 CARTON (50633-110-12) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (50633-110-11) |
| Marketing Start Date | 2000-02-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |