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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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
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 2026-06-01
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