Home NDC 60492-0075 BAT
Product NDC 60492-0075
11-digit product format 604920075
Labeler code 60492
Product ID 60492-0075_2e94a3f2-2cd8-40bb-ae96-80dd2928c797
Type PLASMA DERIVATIVE
Nonproprietary name Botulism Antitoxin Heptavalent
Dosage form LIQUID
Route INTRAVENOUS
Labeler Emergent BioSolutions Canada Inc
Application BLA125462
Marketing category BLA
Marketing start 2013-03-01
Substance EQUINE BOTULINUM NEUROTOXIN A IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN B IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN C IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN D IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN E IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN F IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN G IMMUNE FAB2
Active strength 4500; 3300; 3000; 600; 5100; 3000; 600 [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base BAT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EQUINE BOTULINUM NEUROTOXIN A IMMUNE FAB2 4500 [iU]/10mL EQUINE BOTULINUM NEUROTOXIN B IMMUNE FAB2 3300 [iU]/10mL EQUINE BOTULINUM NEUROTOXIN C IMMUNE FAB2 3000 [iU]/10mL EQUINE BOTULINUM NEUROTOXIN D IMMUNE FAB2 600 [iU]/10mL EQUINE BOTULINUM NEUROTOXIN E IMMUNE FAB2 5100 [iU]/10mL EQUINE BOTULINUM NEUROTOXIN F IMMUNE FAB2 3000 [iU]/10mL EQUINE BOTULINUM NEUROTOXIN G IMMUNE FAB2 600 [iU]/10mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60492-0075-1 BAT 50 mL in 1 VIAL, GLASS LIQUID 50 10 60492-0075-2 BAT 6 in 1 CARTON LIQUID 6 10 60492-0075-4 BAT 1 in 1 CARTON LIQUID 1 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60492-0075 BAT (BOTULISM ANTITOXIN HEPTAVALENT) LIQUID [EMERGENT BIOSOLUTIONS CANADA INC.] 9 Current NDC, Legacy NDC, 3 package rows 20210622_9f3c4292-8773-4781-8264-d71c80d3eabd.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1722719 botulism antitoxin heptavalent (A, B, C, D, E, F, G), Equine Injection PSN 9f3c4292-8773-4781-8264-d71c80d3eabd 10 1722719 botulinum neurotoxin A immune FAB2, equine 4500 UNT / botulinum neurotoxin B immune FAB2, equine 3300 UNT / botulinum neurotoxin C immune FAB2, equine 3000 UNT / botulinum neurotoxin D immune FAB2, equine 600 UNT / botulinum neurotoxin E immune FAB2, equine 5100 UNT / botulinum neurotoxin F immune FAB2, equine 3000 UNT / botulinum neurotoxin G immune FAB2, equine 600 UNT Injection SCD 9f3c4292-8773-4781-8264-d71c80d3eabd 10 1722719 botulism antitoxin heptavalent (A, B, C, D, E, F, G), Equine Injection SY 9f3c4292-8773-4781-8264-d71c80d3eabd 10
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60492-0075-1 60492007501 50 mL in 1 VIAL, GLASS 50 ml Historical 60492-0075-2 60492007502 6 VIAL, GLASS in 1 CARTON (60492-0075-2) / 50 mL in 1 VIAL, GLASS (60492-0075-1) 2013-03-01 0000-00-00 No No Current 60492-0075-3 60492007503 20 mL in 1 VIAL, GLASS (60492-0075-3) 20 ml 2013-03-01 0000-00-00 No No Current 60492-0075-4 60492007504 1 VIAL, GLASS in 1 CARTON (60492-0075-4) / 50 mL in 1 VIAL, GLASS (60492-0075-1) 2013-03-01 0000-00-00 No No Current