PEDIARIX
- Product NDC
- 58160-811
- 11-digit product format
- 581600811
- Labeler code
- 58160
- Product ID
- 58160-811_97c7ea5c-c93e-4bba-9f03-b0e88ed68439
- Type
- VACCINE
- Nonproprietary name
- Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- GlaxoSmithKline Biologicals SA
- Application
- BLA103907
- 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); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)
- Active strength
- 25; 8; 25; 10; 25; 10; 40; 8; 32 ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; ug/.5mL; [iU]/.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], 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], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [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
- PEDIARIX
- Listing expiration
- 2027-12-31
Active Ingredients#
| 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 |
| HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN | 10 ug/.5mL |
| POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) | 40 [iU]/.5mL |
| POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) | 8 [iU]/.5mL |
| POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) | 32 [iU]/.5mL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58160-811-43 | PEDIARIX | 0.5 mL in 1 SYRINGE | INJECTION, SUSPENSION | 0.5 | 30 | |
| 58160-811-52 | PEDIARIX | 10 in 1 CARTON | INJECTION, SUSPENSION | 10 | 30 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58160-811-43 | ML - Milliliter | 58160-811 | 3c5670be-b5f7-4f83-b2f0-c7dd33d80b21 | 1 | 2013-03-03 |
| 58160-811-52 | ML - Milliliter | 58160-811 | 237e40e5-be1c-46bd-96a8-90c2a32819b8 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58160-811 | PEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 28 | Current NDC, Legacy NDC, 2 package rows | 20240601_b63c4c7d-3dbf-419d-84cc-2c1957b92be7.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 829987 | DTaP-HepB-IPV 0.5 ML Prefilled Syringe | PSN | b63c4c7d-3dbf-419d-84cc-2c1957b92be7 | 30 |
| 829989 | PEDIARIX vaccine 0.5 ML Prefilled Syringe | PSN | b63c4c7d-3dbf-419d-84cc-2c1957b92be7 | 30 |
| 829989 | 0.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 80 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 16 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 64 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled Syringe [PEDIARIX] | SBD | b63c4c7d-3dbf-419d-84cc-2c1957b92be7 | 30 |
| 829987 | 0.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 80 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 16 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 64 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled Syringe | SCD | b63c4c7d-3dbf-419d-84cc-2c1957b92be7 | 30 |
| 829987 | acellular pertussis vaccine 0.058 MG / diphtheria toxoid vaccine 25 UNT / hepatitis B surface antigen vaccine 0.01 MG / poliovirus vaccine inactivated, type 1 (Mahoney) 40 UNT / poliovirus vaccine inactivated, type 2 (MEF-1) 8 UNT / poliovirus vaccine inactivated, type 3 (Saukett) 32 UNT / tetanus toxoid vaccine 10 UNT per 0.5 ML Prefilled Syringe | SY | b63c4c7d-3dbf-419d-84cc-2c1957b92be7 | 30 |
| 829987 | diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B and inactivated poliovirus vaccine (DTaP-HepB-IPV) 0.5 ML Prefilled Syringe | SY | b63c4c7d-3dbf-419d-84cc-2c1957b92be7 | 30 |
| 829987 | DTaP-HepB-IPV 0.5 ML Prefilled Syringe | SY | b63c4c7d-3dbf-419d-84cc-2c1957b92be7 | 30 |
| 829989 | PEDIARIX DTaP-HepB-IPV (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine) 0.5 ML Prefilled Syringe | SY | b63c4c7d-3dbf-419d-84cc-2c1957b92be7 | 30 |
| 829987 | DTaP-HepB-IPV 0.5 ML Prefilled Syringe | PSN | dd047022-e51c-4aa1-bd68-bc23161c3ce3 | 2 |
| 829989 | PEDIARIX vaccine 0.5 ML Prefilled Syringe | PSN | dd047022-e51c-4aa1-bd68-bc23161c3ce3 | 2 |
| 829989 | 0.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 80 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 16 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 64 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled Syringe [PEDIARIX] | SBD | dd047022-e51c-4aa1-bd68-bc23161c3ce3 | 2 |
| 829987 | 0.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 80 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 16 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 64 UNT/ML / tetanus toxoid vaccine, inactivated 20 UNT/ML Prefilled Syringe | SCD | dd047022-e51c-4aa1-bd68-bc23161c3ce3 | 2 |
| 829987 | acellular pertussis vaccine 0.058 MG / diphtheria toxoid vaccine 25 UNT / hepatitis B surface antigen vaccine 0.01 MG / poliovirus vaccine inactivated, type 1 (Mahoney) 40 UNT / poliovirus vaccine inactivated, type 2 (MEF-1) 8 UNT / poliovirus vaccine inactivated, type 3 (Saukett) 32 UNT / tetanus toxoid vaccine 10 UNT per 0.5 ML Prefilled Syringe | SY | dd047022-e51c-4aa1-bd68-bc23161c3ce3 | 2 |
| 829987 | diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B and inactivated poliovirus vaccine (DTaP-HepB-IPV) 0.5 ML Prefilled Syringe | SY | dd047022-e51c-4aa1-bd68-bc23161c3ce3 | 2 |
| 829987 | DTaP-HepB-IPV 0.5 ML Prefilled Syringe | SY | dd047022-e51c-4aa1-bd68-bc23161c3ce3 | 2 |
| 829989 | PEDIARIX DTaP-HepB-IPV (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine) 0.5 ML Prefilled Syringe | SY | dd047022-e51c-4aa1-bd68-bc23161c3ce3 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58160-811-43 | 58160081143 | 0.5 mL in 1 SYRINGE | 0.5 ml | Historical | ||||
| 58160-811-52 | 58160081152 | 10 SYRINGE in 1 CARTON (58160-811-52) / .5 mL in 1 SYRINGE (58160-811-43) | 10 syringe | 2009-07-24 | 0000-00-00 | No | No | Current |