Daptacel Injection, Suspension
NDC Package 49281-286-01

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

Package Information

Daptacel (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen) injection is dAPTACEL® is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five-dose series in infants and children 6 weeks through 6 years of age (prior to seventh birthday). This formulation utilizes a injection, suspension delivery system. Marketed by Sanofi Vaccines Us Inc., this product is identified by NDC 49281-286 and is authorized under FDA application BLA103666.

Identification & Billing

NDC Package Code
49281-286-01
Package Description
1 VIAL in 1 PACKAGE / .5 mL in 1 VIAL (49281-286-58)
Product Code
49281-286
11-Digit Billing Format
49281028601
RxNorm Crosswalk
  • RxCUI: 1300308 - DTaP (generic for Daptacel) 0.5 ML Injection
  • RxCUI: 1300308 - 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.01 MG/ML / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 0.01 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.006 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.02 MG/ML / diphtheria toxoid vaccine, inactivated 30 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Injection
  • RxCUI: 1300308 - Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 5 MCG / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 5 MCG / Bordetella pertussis pertactin vaccine, inactivated 3 MCG / Bordetella pertussis toxoid vaccine, inactivated 10 MCG / diphtheria toxoid vaccine 15 UNT / tetanus toxoid vaccine 5 UNT per 0.5 ML Injection
  • RxCUI: 1300308 - diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP generic for Daptacel) 0.5 ML Injection
  • RxCUI: 1300308 - DTaP (diphtheria toxoid vaccine, inactivated 15 UNT / tetanus toxoid vaccine, inactivated 5 UNT / acellular pertussis vaccine, inactivated 23 MCG) per 0.5 ML Injection

Clinical Specifications

Proprietary Name
Daptacel
Non-Proprietary Name
Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated), Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated), Bordetella Pertussis Toxoid Antigen (glutaraldehyde Inactivated), Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated), Bordetella Pertussis Pertactin Antigen, And Bordetella Pertussis Fimbriae 2/3 Antigen
Substance Name
Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated); Bordetella Pertussis Fimbriae 2/3 Antigen; Bordetella Pertussis Pertactin Antigen; Bordetella Pertussis Toxoid Antigen (glutaraldehyde Inactivated); Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated); Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)
Dosage Form
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
Pharmacologic Class
Usage Information
DAPTACEL® is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five-dose series in infants and children 6 weeks through 6 years of age (prior to seventh birthday).

Regulatory & Marketing

Labeler Name
Sanofi Vaccines Us Inc.
Product Type
Vaccine
FDA Application #
BLA103666
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-14-2002
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49281-286). Click a package code to view its specific billing and regulatory data.

49281-286-05
5 VIAL in 1 PACKAGE / .5 mL in 1 VIAL (49281-286-58)
49281-286-10
10 VIAL in 1 PACKAGE / .5 mL in 1 VIAL (49281-286-58)

* 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 49281-286-01 identifies a specific commercial package of 1 vial in 1 package / .5 ml in 1 vial (49281-286-58) of Daptacel, a vaccine label labeled by Sanofi Vaccines Us Inc.. This injection, suspension is formulated for intramuscular use and contains bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated); bordetella pertussis fimbriae 2/3 antigen; bordetella pertussis pertactin antigen; bordetella pertussis toxoid antigen (glutaraldehyde inactivated); clostridium tetani toxoid antigen (formaldehyde inactivated); corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) 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 Sanofi Vaccines Us Inc. on May 14, 2002. The current certification is valid through December 31, 2027.

How is this Sanofi Vaccines Us Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49281028601. 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 (5-3-2)
49281-286-01
11-Digit CMS (5-4-2)
49281-0286-01

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