Home NDC 58160-742 Arepanrix
Product NDC 58160-742
11-digit product format 581600742
Labeler code 58160
Product ID 58160-742_9c273f68-dc37-4307-948e-e530bd124207
Type VACCINE
Nonproprietary name Influenza A H5 Monovalent Vaccine
Dosage form KIT
Labeler GlaxoSmithKline Biologicals SA
Application BLA125419
Marketing category BLA
Marketing start 2026-05-11
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Arepanrix
Listing expiration 2027-12-31 DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58160-742-25 Arepanrix 1 in 1 CARTON KIT 1 1
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125419 Arepanrix Influenza A [H5] Monovalent Vaccine, Adjuvanted 351(a) Disc 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58160-742-25 58160074225 1 KIT in 1 CARTON (58160-742-25) * 10 VIAL in 1 CARTON (58160-753-19) / 2.5 mL in 1 VIAL (58160-753-01) * 10 VIAL in 1 CARTON (58160-855-19) / 2.5 mL in 1 VIAL (58160-855-01) 1 kit 2026-05-11 No No Current