NDC 49281-286
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
DAPTACEL is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Sanofi Pasteur Inc.. The primary component is 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; Bordetella Pertussis Fimbriae 2/3 Antigen.
| Product ID | 49281-286_037e3cb5-7716-4c45-a789-7b83fd930af9 |
| NDC | 49281-286 |
| Product Type | Vaccine |
| Proprietary Name | DAPTACEL |
| Generic 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 |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2002-05-14 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103666 |
| Labeler Name | Sanofi Pasteur Inc. |
| Substance 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; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN |
| Active Ingredient Strength | 15 [Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
| Pharm Classes | Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pertussis Vaccine [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [CS],Vaccines, Inactivated [CS],Pertussis Vaccine [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Diphtheria Toxoid [CS],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Tetanus Toxoid [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 49281-286-01
1 VIAL in 1 PACKAGE (49281-286-01) > .5 mL in 1 VIAL (49281-286-58)
| Marketing Start Date | 2002-05-14 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 49281-286-10 [49281028610]
DAPTACEL INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103666 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2002-05-14 |
NDC 49281-286-05 [49281028605]
DAPTACEL INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103666 |
| Product Type | VACCINE |
| Marketing Start Date | 2002-05-14 |
NDC 49281-286-01 [49281028601]
DAPTACEL INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103666 |
| Product Type | VACCINE |
| Marketing Start Date | 2002-05-14 |
NDC 49281-286-58 [49281028658]
DAPTACEL INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103666 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2013-11-11 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | 15 [Lf]/.5mL |
Pharmacological Class
- Inactivated Bordetella Pertussis Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Vaccines
- Inactivated [CS]
- Pertussis Vaccine [CS]
- Inactivated Bordetella Pertussis Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Pertussis Vaccine [CS]
- Vaccines
- Inactivated [CS]
- Pertussis Vaccine [CS]
- Inactivated Bordetella Pertussis Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Vaccines
- Inactivated [CS]
- Inactivated Corynebacterium Diphtheriae Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Vaccines
- Inactivated [CS]
- Diphtheria Toxoid [CS]
- Inactivated Clostridium Tetani Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Vaccines
- Inactivated [CS]
- Tetanus Toxoid [CS]
- Inactivated Bordetella Pertussis Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Vaccines
- Inactivated [CS]
- Pertussis Vaccine [CS]
- Inactivated Bordetella Pertussis Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Pertussis Vaccine [CS]
- Vaccines
- Inactivated [CS]
- Pertussis Vaccine [CS]
- Inactivated Bordetella Pertussis Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Vaccines
- Inactivated [CS]
- Inactivated Corynebacterium Diphtheriae Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Vaccines
- Inactivated [CS]
- Diphtheria Toxoid [CS]
- Inactivated Clostridium Tetani Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Vaccines
- Inactivated [CS]
- Tetanus Toxoid [CS]
Trademark Results [DAPTACEL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DAPTACEL 76281766 2647103 Live/Registered |
SANOFI PASTEUR INC. 2001-07-06 |
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