Home NDC 50633-120-11 DigiFab
Product NDC 50633-120
Requested package NDC 50633-120-11
11-digit product format 506330120
Labeler code 50633
Product ID 50633-120_5ca2559c-b619-0160-e063-6394a90a1675
Type PLASMA DERIVATIVE
Nonproprietary name ovine digoxin immune fab
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler BTG International Inc.
Application BLA103910
Marketing category BLA
Marketing start 2001-08-31
Marketing end 2028-02-29
Substance OVINE DIGOXIN IMMUNE FAB
Active strength 40 mg/1
Pharmacologic classes Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
NDC exclude flag No
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50633-120 50633-120-11 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50633-120 50633-120-11 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base DigiFab 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 50633-120-11 DigiFab 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 8 50633-120-12 DigiFab 1 in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OVINE DIGOXIN IMMUNE FAB ACTIVE INGREDIENT YB12NQZ1YN DIGIFAB (OVINE DIGOXIN IMMUNE FAB) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] 2 DIGOXIN ACTIVE MOIETY 73K4184T59 DIGIFAB (OVINE DIGOXIN IMMUNE FAB) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A DIGIFAB (OVINE DIGOXIN IMMUNE FAB) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] 2 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B DIGIFAB (OVINE DIGOXIN IMMUNE FAB) INJECTION, POWDER, FOR SOLUTION [BTG INTERNATIONAL INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50633-120 DIGIFAB (OVINE DIGOXIN IMMUNE FAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.] 8 Current NDC, Legacy NDC, 2 package rows 20250129_c05ee6a5-c98b-45f4-83fd-40781639d653.zip
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 2026-09-01
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 50633-120-11 50633012011 1 VIAL, GLASS in 1 CARTON (50633-120-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (50633-120-12) 2001-08-31 2028-02-29 No No Current