NDC 58160-810
INFANRIX
Diphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed
INFANRIX is a Intramuscular Suspension in the Vaccine category. It is labeled and distributed by Glaxosmithkline Biologicals Sa. The primary component is Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated); Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated); Bordetella Pertussis Toxoid Antigen (formaldehyde, Glutaraldehyde Inactivated); Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated); Bordetella Pertussis Pertactin Antigen (formaldehyde Inactivated).
| Product ID | 58160-810_61ec630a-fc26-4878-b587-636909a91195 |
| NDC | 58160-810 |
| Product Type | Vaccine |
| Proprietary Name | INFANRIX |
| Generic Name | Diphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed |
| Dosage Form | Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2009-07-24 |
| Marketing Category | BLA / BLA |
| Application Number | BLA103647 |
| Labeler Name | GlaxoSmithKline Biologicals SA |
| Substance Name | CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) |
| Active Ingredient Strength | 10 [iU]/.5mL; [iU]/.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],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] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 58160-810-11
10 VIAL in 1 CARTON (58160-810-11) > .5 mL in 1 VIAL (58160-810-01)
| Marketing Start Date | 2009-07-24 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 58160-810-43 [58160081043]
INFANRIX SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103647 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2010-09-01 |
NDC 58160-810-41 [58160081041]
INFANRIX SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103647 |
| Product Type | VACCINE |
| Marketing Start Date | 2009-07-24 |
| Marketing End Date | 2013-01-02 |
NDC 58160-810-51 [58160081051]
INFANRIX SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103647 |
| Product Type | VACCINE |
| Marketing Start Date | 2010-02-24 |
| Marketing End Date | 2013-01-02 |
NDC 58160-810-11 [58160081011]
INFANRIX SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103647 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2009-07-24 |
NDC 58160-810-52 [58160081052]
INFANRIX SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103647 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2010-09-01 |
NDC 58160-810-46 [58160081046]
INFANRIX SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103647 |
| Product Type | VACCINE |
| Marketing Start Date | 2009-07-24 |
| Marketing End Date | 2012-03-21 |
NDC 58160-810-01 [58160081001]
INFANRIX SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA103647 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2009-07-24 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | 10 [iU]/.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 "INFANRIX" or generic name "Diphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 50090-2883 | INFANRIX | Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed |
| 58160-810 | INFANRIX | Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed |
Trademark Results [INFANRIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INFANRIX 75121742 2171713 Live/Registered |
GLAXOSMITHKLINE BIOLOGICALS S.A. 1996-06-04 |
 INFANRIX 74385270 2095412 Live/Registered |
GLAXOSMITHKLINE BIOLOGICALS S.A. 1993-04-29 |
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