Home NDC 73441-800 OMISIRGE
Product NDC 73441-800
11-digit product format 734410800
Labeler code 73441
Product ID 73441-800_d383cdf1-017c-46c2-9130-d6e5c2a7dcf7
Type CELLULAR THERAPY
Nonproprietary name omidubicel-onlv
Dosage form KIT
Labeler Gamida Cell Inc.
Application BLA125738
Marketing category BLA
Marketing start 2023-05-01
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 OMISIRGE
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2637360 Internal RxNorm lookup 2637362 Internal RxNorm lookup 2637363 Internal RxNorm lookup 2637364 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73441-100-01 OMISIRGE 20 mL in 1 BAG SUSPENSION 20 mL 800000000 in 100mL 8 73441-200-01 OMISIRGE 10 mL in 1 BAG SUSPENSION 10 mL 400000000 in 50mL 8 73441-800-04 OMISIRGE 1 in 1 KIT KIT 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73441-800 OMISIRGE (OMIDUBICEL-ONLV) KIT [GAMIDA CELL INC.] 5 Current NDC, 3 package rows 20250115_979803c9-956c-42e7-9d75-c37cc4e90632.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125738 OMISIRGE omidubicel-onlv 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2637364 {1 (100 ML omidubicel-onlv 8000000 CELLS/ML Injection) / 1 (50 ML omidubicel-onlv 8000000 CELLS/ML Injection) } Pack [Omisirge] BPCK 979803c9-956c-42e7-9d75-c37cc4e90632 8 2637363 {1 (100 ML omidubicel-onlv 8000000 CELLS/ML Injection) / 1 (50 ML omidubicel-onlv 8000000 CELLS/ML Injection) } Pack GPCK 979803c9-956c-42e7-9d75-c37cc4e90632 8 2637362 omidubicel-onlv 400,000,000 CELLS in 50 ML Injection PSN 979803c9-956c-42e7-9d75-c37cc4e90632 8 2637360 omidubicel-onlv 800,000,000 CELLS in 100 ML Injection PSN 979803c9-956c-42e7-9d75-c37cc4e90632 8 2637363 omidubicel-onlv Cultured and Non-Cultured Injection Pack PSN 979803c9-956c-42e7-9d75-c37cc4e90632 8 2637364 Omisirge Cultured and Non-Cultured Injection Pack PSN 979803c9-956c-42e7-9d75-c37cc4e90632 8 2637360 100 ML omidubicel-onlv 8000000 CELLS/ML Injection SCD 979803c9-956c-42e7-9d75-c37cc4e90632 8 2637362 50 ML omidubicel-onlv 8000000 CELLS/ML Injection SCD 979803c9-956c-42e7-9d75-c37cc4e90632 8 2637362 omidubicel-onlv 400,000,000 CELLS per 50 ML Injection SY 979803c9-956c-42e7-9d75-c37cc4e90632 8 2637360 omidubicel-onlv 800,000,000 CELLS per 100 ML Injection SY 979803c9-956c-42e7-9d75-c37cc4e90632 8 2637363 omidubicel-onlv Cultured and Non-Cultured Injection Pack SY 979803c9-956c-42e7-9d75-c37cc4e90632 8 2637364 Omisirge Cultured and Non-Cultured Injection Pack SY 979803c9-956c-42e7-9d75-c37cc4e90632 8
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 73441-100-01 73441010001 20 mL in 1 BAG 20 ml Historical 73441-200-01 73441020001 10 mL in 1 BAG 10 ml Historical 73441-800-04 73441080004 1 KIT in 1 KIT (73441-800-04) * 10 mL in 1 BAG (73441-200-01) * 40 mL in 1 BAG (73441-400-01) * 20 mL in 1 BAG (73441-100-01) * 80 mL in 1 BAG (73441-300-01) 1 kit 2023-05-01 No No Current