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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
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 2026-06-01
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