NDC 68403-1100

BabyBIG

Human Botulinum Neurotoxin A/b Immune Globulin

BabyBIG is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by California Department Of Public Health. The primary component is Human Botulinum Neurotoxin A/b Immune Globulin.

• Product ID: 68403-1100_4042541e-3acb-44f3-ad61-0a6a5becffb0
• NDC: 68403-1100
• Product Type: Human Prescription Drug
• Proprietary Name: BabyBIG
• Generic Name: Human Botulinum Neurotoxin A/b Immune Globulin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2003-10-23
• Marketing Category: BLA / BLA
• Application Number: BLA125034
• Labeler Name: CALIFORNIA DEPARTMENT OF PUBLIC HEALTH
• Substance Name: HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Bacterial Neurotoxin Neutralization [MoA],Antitoxins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68403-1100-7

1 VIAL, SINGLE-USE in 1 CARTON (68403-1100-7) > 2 mL in 1 VIAL, SINGLE-USE (68403-1100-6)

• Marketing Start Date: 2003-10-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68403-1100-6 [68403110006]

BabyBIG INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125034
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-10-23

Drug Details

Active Ingredients

Ingredient	Strength
HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN	50 mg/mL

OpenFDA Data

• SPL SET ID: 9ec59262-35c1-4d8e-8451-a7cfbacb0675
• Manufacturer:
  • CALIFORNIA DEPARTMENT OF PUBLIC HEALTH
• UNII:
  • X641Y30OA7
• RxNorm Concept Unique ID - RxCUI:
  • 544495
  • 544491

Pharmacological Class

• Human Immunoglobulin G [EPC]
• Passively Acquired Immunity [PE]
• Bacterial Neurotoxin Neutralization [MoA]
• Antitoxins [CS]