BabyBIG
These highlights do not include all the information needed to use BabyBIG, [Botulism Immune Globulin Intravenous (Human)], safely and effectively. See full prescribing information for BabyBIG. BabyBIG [Botulism Immune Globulin Intravenous (Human) (BIG-IV)] Lyophilized Powder for Reconstitution and Injection Initial U.S. Approval: 2003
Approved
Approval ID
9ec59262-35c1-4d8e-8451-a7cfbacb0675
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2021
Manufacturers
FDA
CALIFORNIA DEPARTMENT OF PUBLIC HEALTH
DUNS: 004519216
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
human botulinum neurotoxin a/b immune globulin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68403-1100
Application NumberBLA125034
Product Classification
M
Marketing Category
C73585
G
Generic Name
human botulinum neurotoxin a/b immune globulin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 30, 2021
FDA Product Classification
INGREDIENTS (4)
human botulinum neurotoxin a/b immune globulinActive
Quantity: 50 mg in 1 mL
Code: X641Y30OA7
Classification: ACTIB
sucroseInactive
Quantity: 50 mg in 1 mL
Code: C151H8M554
Classification: IACT
albumin humanInactive
Quantity: 10 mg in 1 mL
Code: ZIF514RVZR
Classification: IACT
sodium phosphate, monobasic, anhydrousInactive
Code: KH7I04HPUU
Classification: IACT