Home NDC 0026-3826 Kovaltry
Product NDC 0026-3826
11-digit product format 000263826
Labeler code 0026
Product ID 0026-3826_f4bed724-db3e-448e-8947-2f6a6913f1ee
Type PLASMA DERIVATIVE
Nonproprietary name Antihemophilic Factor (Recombinant)
Dosage form KIT
Labeler Bayer HealthCare LLC
Application BLA125574
Marketing category BLA
Marketing start 2016-03-17
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Kovaltry
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 0026-3826-50 Kovaltry 1 in 1 BOX KIT 1 18 0026-3826-99 Kovaltry 1 in 1 BOX KIT 1 18 0026-4826-01 Kovaltry 5 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 5 mL 2000 [iU] in 5mL 18 0026-4826-99 Kovaltry 5 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 5 mL 2000 [iU] in 5mL 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0026-3826 KOVALTRY (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [BAYER HEALTHCARE LLC] 16 Current NDC, Legacy NDC, 4 package rows 20241010_89ba5048-469c-4f08-a173-81b0c6f3004d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0026-3826-50 00026382650 1 KIT in 1 BOX (0026-3826-50) * 5 mL in 1 VIAL, SINGLE-USE (0026-4826-99) * 5 mL in 1 SYRINGE (0026-0426-15) * 5 mL in 1 VIAL, SINGLE-USE (0026-4826-01) * 5 mL in 1 SYRINGE (0026-0426-05) 1 kit 2016-03-17 0000-00-00 No No Current 0026-3826-99 00026382699 1 KIT in 1 BOX (0026-3826-99) * 5 mL in 1 VIAL, SINGLE-USE (0026-4826-99) * 5 mL in 1 SYRINGE (0026-0426-15) * 5 mL in 1 VIAL, SINGLE-USE (0026-4826-01) * 5 mL in 1 SYRINGE (0026-0426-05) 1 kit 2016-03-17 0000-00-00 No No Current 0026-4826-01 00026482601 5 mL in 1 VIAL, SINGLE-USE 5 ml Historical 0026-4826-99 00026482699 5 mL in 1 VIAL, SINGLE-USE 5 ml Historical