Home NDC 49281-190 IMOGAM RABIES-HT
Product NDC 49281-190
11-digit product format 492810190
Labeler code 49281
Product ID 49281-190_8026005f-7587-47fe-bb78-ec6247a3434b
Type PLASMA DERIVATIVE
Nonproprietary name HUMAN RABIES VIRUS IMMUNE GLOBULIN
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Sanofi Pasteur Inc.
Application BLA103932
Marketing category BLA
Marketing start 1984-04-27
Marketing end 0000-00-00
Substance HUMAN RABIES VIRUS IMMUNE GLOBULIN
Active strength 150 [iU]/mL
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49281-190-20 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49281-190-20 f5e01cc5f278…a2eaf40c39c3…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49281-190 IMOGAM RABIES-HT (HUMAN RABIES VIRUS IMMUNE GLOBULIN) INJECTION, SOLUTION [SANOFI PASTEUR INC.] 13 Legacy NDC 20210109_bf845cf8-7c01-46c0-97cb-e73a121ff3a7.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103932 Imogam Rabies Immune Globulin (Human) 351(a) Disc 2026-08-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49281-190-20 49281019020 1 VIAL, SINGLE-DOSE in 1 CARTON (49281-190-20) > 2 mL in 1 VIAL, SINGLE-DOSE (49281-190-58) 1984-04-27 0000-00-00 No No Current