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NDC 49281-0400-05 Adacel 5; 5; 3; 2.5; 5; 2 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL Details
Adacel 5; 5; 3; 2.5; 5; 2 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL
Adacel is a INTRAMUSCULAR INJECTION, SUSPENSION in the VACCINE category. It is labeled and distributed by Sanofi Pasteur Inc.. The primary component is 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 TOXO.
Product Information
| NDC | 49281-0400 |
|---|---|
| Product ID | 49281-400_54c1ecd8-c9cc-4c58-b42d-345d03eb5e5b |
| Associated GPIs | 18990003221815 |
| GCN Sequence Number | 063698 |
| GCN Sequence Number Description | diph,pertuss(acell),tet vac/PF VIAL 2-2.5-5/.5 INTRAMUSC |
| HIC3 | W7Z |
| HIC3 Description | VACCINE/TOXOID PREPARATIONS,COMBINATIONS |
| GCN | 99416 |
| HICL Sequence Number | 035400 |
| HICL Sequence Number Description | DIPHTHERIA,PERTUSSIS(ACELLULAR),TETANUS VACCINE/PF |
| Brand/Generic | Brand |
| Proprietary Name | Adacel |
| Proprietary Name Suffix | TDaP |
| Non-Proprietary Name | CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN ( |
| Product Type | VACCINE |
| Dosage Form | INJECTION, SUSPENSION |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 5; 5; 3; 2.5; 5; 2 |
| Active Ingredient Units | ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL |
| 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 TOXO |
| Labeler Name | Sanofi Pasteur Inc. |
| Pharmaceutical Class | Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordet |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125111 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 49281-0400-05 (49281040005)
| NDC Package Code | 49281-400-05 |
|---|---|
| Billing NDC | 49281040005 |
| Package | 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 |
| Pricing Information | N/A |