INFANRIX
- Product NDC
- 58160-810
- 11-digit product format
- 581600810
- Labeler code
- 58160
- Product ID
- 58160-810_3370ee1e-9acd-4f25-86c0-c6d7a32c1e93
- Type
- VACCINE
- Nonproprietary name
- Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
- Dosage form
- SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- GlaxoSmithKline Biologicals SA
- Application
- BLA103647
- Marketing category
- BLA
- Marketing start
- 2009-07-24
- Substance
- BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
- Active strength
- 25; 8; 25; 10; 25 ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL
- Pharmacologic classes
- 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 Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- INFANRIX
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) | 25 ug/.5mL |
| BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) | 8 ug/.5mL |
| BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) | 25 ug/.5mL |
| CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | 10 [iU]/.5mL |
| CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | 25 [iU]/.5mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58160-810-43 | INFANRIX | 0.5 mL in 1 SYRINGE | SUSPENSION | 0.5 | | 29 |
| 58160-810-52 | INFANRIX | 10 in 1 CARTON | SUSPENSION | 10 | | 29 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58160-810 | INFANRIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS VACCINE ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 27 | Current NDC, Legacy NDC, 2 package rows | 20241208_de16dd6a-859b-4180-c6af-f930be14f26a.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1300382 | DTaP (generic for Infanrix) 0.5 ML Prefilled Syringe | PSN | de16dd6a-859b-4180-c6af-f930be14f26a | 29 |
| 1300384 | INFANRIX vaccine 0.5 ML Prefilled Syringe | PSN | de16dd6a-859b-4180-c6af-f930be14f26a | 29 |
| 1300384 | 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.05 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.016 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.05 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled Syringe [Infanrix] | SBD | de16dd6a-859b-4180-c6af-f930be14f26a | 29 |
| 1300382 | 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.05 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.016 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.05 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled Syringe | SCD | de16dd6a-859b-4180-c6af-f930be14f26a | 29 |
| 1300382 | Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 25 MCG / Bordetella pertussis pertactin vaccine, inactivated 8 MCG / Bordetella pertussis toxoid vaccine, inactivated 25 MCG / diphtheria toxoid vaccine, inactivated 25 UNT / tetanus toxoid vaccine, inactivated 10 UNT per 0.5 ML Prefilled Syringe | SY | de16dd6a-859b-4180-c6af-f930be14f26a | 29 |
| 1300382 | diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP generic for Infanrix) 0.5 ML Prefilled Syringe | SY | de16dd6a-859b-4180-c6af-f930be14f26a | 29 |
| 1300382 | DTaP (diphtheria toxoid vaccine, inactivated 25 UNT / tetanus toxoid vaccine, inactivated 10 UNT / acellular pertussis vaccine, inactivated 25 UNT) per 0.5 ML Prefilled Syringe | SY | de16dd6a-859b-4180-c6af-f930be14f26a | 29 |
| 1300384 | Infanrix (Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 25 MCG / Bordetella pertussis pertactin vaccine, inactivated 8 MCG / Bordetella pertussis toxoid vaccine, inactivated 25 MCG / diphtheria toxoid vaccine, inactivated 25 UNT / tetanus toxoid vaccine, inactivated 10 UNT) per 0.5 ML Prefilled Syringe | SY | de16dd6a-859b-4180-c6af-f930be14f26a | 29 |
| 1300384 | Infanrix DTaP (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) 0.5 ML Prefilled Syringe | SY | de16dd6a-859b-4180-c6af-f930be14f26a | 29 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58160-810-11 | 58160081011 | 10 VIAL in 1 CARTON (58160-810-11) > .5 mL in 1 VIAL (58160-810-01) | 10 vial | 2009-07-24 | 0000-00-00 | No | No | Current |
| 58160-810-43 | 58160081043 | 0.5 mL in 1 SYRINGE | 0.5 ml | | | | | Historical |
| 58160-810-52 | 58160081052 | 10 SYRINGE in 1 CARTON (58160-810-52) / .5 mL in 1 SYRINGE (58160-810-43) | 10 syringe | 2009-07-24 | 0000-00-00 | No | No | Current |