P39ZG8H)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SUCROSE (UNII: C151H8M554)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0026-4828-01 5 mL in 1 VIAL, SINGLE-USE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2 NDC:0026-4828-99 5 mL in 1 VIAL, SINGLE-USE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125574 03/17/2016
Part 2 of 2
DILUENT
water solution
PRODUCT INFORMATION
Item Code (Source) NDC:0026-0426
Route of Administration INTRAVENOUS
INACTIVE INGREDIENTS
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0026-0426-05 5 mL in 1 SYRINGE; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125574 03/17/2016
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125574 03/17/2016
LABELER - BAYER HEALTHCARE LLC (127769128)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Bayer HealthCare LLC 127769128 MANUFACTURE(0026-3821, 0026-4821, 0026-0426, 0026-3822, 0026-4822, 0026-0426, 0026-3824, 0026-4824, 0026-0426, 0026-3826, 0026-4826, 0026-0426, 0026-3828, 0026-4828, 0026-0426) , API MANUFACTURE(0026-3821, 0026-4821, 0026-0426, 0026-3822, 0026-4822, 0026-0426, 0026-3824, 0026-4824, 0026-0426, 0026-3826, 0026-4826, 0026-0426, 0026-3828, 0026-4828, 0026-0426)
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89ba5048-469c-4f08-a173-81b0c6f3004d
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