NDC 49281-400
Adacel TDaP
Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated), Corynebacterium Diphtheriae 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
Adacel TDaP is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Sanofi Pasteur Inc.. The primary component is Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated); Corynebacterium Diphtheriae 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 | 49281-400_3aca07e6-db77-4e8b-9a20-5d07b8c658b7 |
| NDC | 49281-400 |
| Product Type | Vaccine |
| Proprietary Name | Adacel TDaP |
| Generic Name | Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated), Corynebacterium Diphtheriae 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 | 2005-06-10 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125111 |
| Labeler Name | Sanofi Pasteur Inc. |
| Substance Name | CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE 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 | 5 [Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
| Pharm Classes | Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Tetanus Toxoid [CS],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Diphtheria Toxoid [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 Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pertussis Vaccine [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 49281-400-05
5 VIAL in 1 PACKAGE (49281-400-05) > .5 mL in 1 VIAL (49281-400-58)
| Marketing Start Date | 2005-06-10 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 49281-400-58 [49281040058]
Adacel TDaP INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125111 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2013-08-23 |
NDC 49281-400-88 [49281040088]
Adacel TDaP INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125111 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2013-08-23 |
NDC 49281-400-20 [49281040020]
Adacel TDaP INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125111 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2017-11-17 |
NDC 49281-400-89 [49281040089]
Adacel TDaP INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125111 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2017-11-17 |
NDC 49281-400-15 [49281040015]
Adacel TDaP INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125111 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2005-06-10 |
NDC 49281-400-10 [49281040010]
Adacel TDaP INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125111 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2005-06-10 |
NDC 49281-400-05 [49281040005]
Adacel TDaP INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125111 |
| Product Type | VACCINE |
| Marketing Start Date | 2005-06-10 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | 5 [Lf]/.5mL |
Pharmacological Class
- Inactivated Clostridium Tetani Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Vaccines
- Inactivated [CS]
- Tetanus Toxoid [CS]
- Inactivated Corynebacterium Diphtheriae Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Vaccines
- Inactivated [CS]
- Diphtheria Toxoid [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 Bordetella Pertussis Vaccine [EPC]
- Actively Acquired Immunity [PE]
- Vaccines
- Inactivated [CS]
- Pertussis Vaccine [CS]
NDC Crossover Matching brand name "Adacel TDaP" or generic name "Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated), Corynebacterium Diphtheriae 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"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 49281-400 | Adacel | CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE 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 |
| 50090-1079 | CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE 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 | CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE 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 |
Trademark Results [Adacel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADACEL 78469483 3034913 Live/Registered |
SANOFI PASTEUR INC. 2004-08-18 |
 ADACEL 78261501 3053019 Live/Registered |
ADACEL INC. 2003-06-12 |
 ADACEL 76473861 3068614 Live/Registered |
SANOFI PASTEUR INC. 2002-12-11 |
 ADACEL 75704888 not registered Dead/Abandoned |
Connaught Technology Corporation 1999-05-14 |
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