CroFab
- Product NDC
- 50633-110
- 11-digit product format
- 506330110
- Labeler code
- 50633
- Product ID
- 50633-110_4dd69679-7e85-01da-e063-6294a90ac320
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- ovine crotalidae venoms immune fab
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- BTG International Inc.
- Application
- BLA103788
- Marketing category
- BLA
- Marketing start
- 2000-10-02
- Substance
- AGKISTRODON PISCIVORUS IMMUNE FAB ANTIVENIN (OVINE); CROTALUS ADAMANTEUS IMMUNE FAB ANTIVENIN (OVINE); CROTALUS ATROX IMMUNE FAB ANTIVENIN (OVINE); CROTALUS SCUTULATUS IMMUNE FAB ANTIVENIN (OVINE)
- Active strength
- 1; 1; 1; 1 g/1; g/1; g/1; g/1
- Pharmacologic classes
- 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 Acquired Immunity [PE], Passively Acquired Immunity [PE], Passively Acquired Immunity [PE], Venom Neutralization [MoA], Venom Neutralization [MoA], Venom Neutralization [MoA], Venom Neutralization [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CroFab
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AGKISTRODON PISCIVORUS IMMUNE FAB ANTIVENIN (OVINE) | 1 g/1 |
| CROTALUS ADAMANTEUS IMMUNE FAB ANTIVENIN (OVINE) | 1 g/1 |
| CROTALUS ATROX IMMUNE FAB ANTIVENIN (OVINE) | 1 g/1 |
| CROTALUS SCUTULATUS IMMUNE FAB ANTIVENIN (OVINE) | 1 g/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50633-110-11 | CroFab | 1 in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 1 | | 20 |
| 50633-110-12 | CroFab | 2 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 2 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| COTTONMOUTH (AGKISTRODON PISCIVORUS) IMMUNE FAB ANTIVENIN (OVINE) | ACTIVE INGREDIENT | IA6O0K772M | CROFAB (OVINE CROTALIDAE VENOMS IMMUNE FAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.] | 2 | |
| EASTERN DIAMONDBACK RATTLESNAKE (CROTALUS ADAMANTEUS) IMMUNE FAB ANTIVENIN (OVINE) | ACTIVE INGREDIENT | A4229A7019 | CROFAB (OVINE CROTALIDAE VENOMS IMMUNE FAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.] | 2 | |
| MOJAVE RATTLESNAKE (CROTALUS SCUTULATUS) IMMUNE FAB ANTIVENIN (OVINE) | ACTIVE INGREDIENT | 7WZ1744G86 | CROFAB (OVINE CROTALIDAE VENOMS IMMUNE FAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.] | 2 | |
| WESTERN DIAMONDBACK RATTLESNAKE (CROTALUS ATROX) IMMUNE FAB ANTIVENIN (OVINE) | ACTIVE INGREDIENT | RBR61YAJ4V | CROFAB (OVINE CROTALIDAE VENOMS IMMUNE FAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.] | 2 | |
| COTTONMOUTH (AGKISTRODON PISCIVORUS) IMMUNE FAB ANTIVENIN (OVINE) | ACTIVE MOIETY | IA6O0K772M | CROFAB (OVINE CROTALIDAE VENOMS IMMUNE FAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.] | 2 | |
| EASTERN DIAMONDBACK RATTLESNAKE (CROTALUS ADAMANTEUS) IMMUNE FAB ANTIVENIN (OVINE) | ACTIVE MOIETY | A4229A7019 | CROFAB (OVINE CROTALIDAE VENOMS IMMUNE FAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.] | 2 | |
| MOJAVE RATTLESNAKE (CROTALUS SCUTULATUS) IMMUNE FAB ANTIVENIN (OVINE) | ACTIVE MOIETY | 7WZ1744G86 | CROFAB (OVINE CROTALIDAE VENOMS IMMUNE FAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.] | 2 | |
| WESTERN DIAMONDBACK RATTLESNAKE (CROTALUS ATROX) IMMUNE FAB ANTIVENIN (OVINE) | ACTIVE MOIETY | RBR61YAJ4V | CROFAB (OVINE CROTALIDAE VENOMS IMMUNE FAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | CROFAB (OVINE CROTALIDAE VENOMS IMMUNE FAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.] | 2 | |
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | 22ADO53M6F | CROFAB (OVINE CROTALIDAE VENOMS IMMUNE FAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50633-110 | CROFAB (OVINE CROTALIDAE VENOMS IMMUNE FAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20241120_77abd784-3387-420d-abdc-4fe97215d233.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50633-110-11 | 50633011011 | 1 in 1 VIAL, GLASS | | | | | Historical |
| 50633-110-12 | 50633011012 | 2 VIAL, GLASS in 1 CARTON (50633-110-12) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (50633-110-11) | 2000-10-02 | 0000-00-00 | No | No | Current |