Home NDC 68403-1100 BabyBIG
Product NDC 68403-1100
11-digit product format 684031100
Labeler code 68403
Product ID 68403-1100_1081f6db-619b-4e42-946c-d278789a588a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name human botulinum neurotoxin a/b immune globulin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler CALIFORNIA DEPARTMENT OF PUBLIC HEALTH
Application BLA125034
Marketing category BLA
Marketing start 2003-10-23
Substance HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN
Active strength 50 mg/mL
Pharmacologic classes Antitoxins [CS], Bacterial Neurotoxin Neutralization [MoA], Human Immunoglobulin G [EPC], Passively Acquired Immunity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base BabyBIG
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X641Y30OA7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 544491 Internal RxNorm lookup 544495 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68403-1100-6 BabyBIG 2 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 2 14 68403-1100-7 BabyBIG 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded human botulinum neurotoxin a/b immune globulin ACTIVE INGREDIENT X641Y30OA7 BABYBIG (HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CALIFORNIA DEPARTMENT OF PUBLIC HEALTH] 9 human botulinum neurotoxin a/b immune globulin ACTIVE MOIETY X641Y30OA7 BABYBIG (HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CALIFORNIA DEPARTMENT OF PUBLIC HEALTH] 9 albumin human INACTIVE INGREDIENT ZIF514RVZR BABYBIG (HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CALIFORNIA DEPARTMENT OF PUBLIC HEALTH] 9 sodium phosphate, monobasic, anhydrous INACTIVE INGREDIENT KH7I04HPUU BABYBIG (HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CALIFORNIA DEPARTMENT OF PUBLIC HEALTH] 9 sucrose INACTIVE INGREDIENT C151H8M554 BABYBIG (HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CALIFORNIA DEPARTMENT OF PUBLIC HEALTH] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68403-1100 BABYBIG (HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CALIFORNIA DEPARTMENT OF PUBLIC HEALTH] 13 Current NDC, Legacy NDC, 2 package rows 20241208_9ec59262-35c1-4d8e-8451-a7cfbacb0675.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BabyBIG HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN CALIFORNIA DEPARTMENT OF PUBLIC HEALTH 9ec59262-35c1-4d8e-8451-a7cfbacb0675 2025-12-08 Warnings, Adverse reactions Exact identifier application number: BLA125034 ndc (product): 68403-1100
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125034 BabyBig Botulism Immune Globulin Intravenous (Human) 351(a) Rx 2026-09-01
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 68403-1100-6 68403110006 2 mL in 1 VIAL, SINGLE-USE 2 ml Historical 68403-1100-7 68403110007 1 VIAL, SINGLE-USE in 1 CARTON (68403-1100-7) / 2 mL in 1 VIAL, SINGLE-USE (68403-1100-6) 2003-10-23 0000-00-00 No No Current