Babybig Injection, Powder, Lyophilized, For Solution
NDC Package 68403-1100-7

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Babybig (human botulinum neurotoxin a/b immune globulin) injection is babyBIG®, Botulism Immune Globulin Intravenous (Human), is indicated for the treatment of infant botulism caused by toxin type A or B in patients below one year of age. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by California Department Of Public Health, this product is identified by NDC 68403-1100 and is authorized under FDA application BLA125034.

Identification & Billing

NDC Package Code
68403-1100-7
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-USE (68403-1100-6)
Product Code
68403-1100
11-Digit Billing Format
68403110007
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Babybig
Non-Proprietary Name
Human Botulinum Neurotoxin A/b Immune Globulin
Substance Name
Human Botulinum Neurotoxin A/b Immune Globulin
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN 50 mg/mL
Pharmacologic Class
Usage Information
BabyBIG®, Botulism Immune Globulin Intravenous (Human), is indicated for the treatment of infant botulism caused by toxin type A or B in patients below one year of age.

Regulatory & Marketing

Labeler Name
California Department Of Public Health
Product Type
Human Prescription Drug
FDA Application #
BLA125034
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-23-2003
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68403-1100-7 identifies a specific commercial package of 1 vial, single-use in 1 carton / 2 ml in 1 vial, single-use (68403-1100-6) of Babybig, a human prescription drug labeled by California Department Of Public Health. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains human botulinum neurotoxin a/b immune globulin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by California Department Of Public Health on October 23, 2003. The current certification is valid through December 31, 2026.

How is this California Department Of Public Health product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68403110007. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
68403-1100-7
11-Digit CMS (5-4-2)
68403-1100-07

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.