KINRIX
- Product NDC
- 58160-812
- 11-digit product format
- 581600812
- Labeler code
- 58160
- Product ID
- 58160-812_0066d4bd-89fc-4bf7-80ce-4d9c49f59244
- Type
- VACCINE
- Nonproprietary name
- Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- GlaxoSmithKline Biologicals SA
- Application
- BLA125260
- Marketing category
- BLA
- Marketing start
- 2008-07-09
- 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); 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; 40; 8; 32 [iU]/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.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
- KINRIX
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) | 25 [iU]/.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 |
| 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 Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 99e684e6-f435-feb8-d2bb-3a546f1cb768 | Product name | 2 | 20161117 |
| 25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c | Product name | 1 | 20160603 |
| b045ad64-0f28-9a02-2f9b-b34d94fb2278 | Product name | 1 | 20140508 |
| b6082387-f592-1148-0844-bd068fd213fb | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58160-812-43 | KINRIX | 0.5 mL in 1 SYRINGE | INJECTION, SUSPENSION | 0.5 | 32 | |
| 58160-812-52 | KINRIX | 10 in 1 CARTON | INJECTION, SUSPENSION | 10 | 32 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58160-812-01 | ML - Milliliter | 58160-812 | 1993cfec-f253-49c2-aa4a-f0dc05fdebc9 | 1 | 2015-07-20 |
| 58160-812-11 | ML - Milliliter | 58160-812 | 21d34a45-d47a-47b8-aa76-913befb15fe9 | 1 | 2013-02-13 |
| 58160-812-43 | ML - Milliliter | 58160-812 | b0f931b8-99eb-401d-a50e-14bd29195b9e | 1 | 2013-08-02 |
| 58160-812-52 | ML - Milliliter | 58160-812 | 0690a18c-1497-4dff-8be7-4bfe6921071c | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58160-812 | KINRIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA] | 31 | Current NDC, Legacy NDC, 2 package rows | 20250525_6b5f89e9-1292-4f13-5590-44c874bf299c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 830555 | DTaP-IPV (generic for Kinrix) 0.5 ML Prefilled Syringe | PSN | 6b5f89e9-1292-4f13-5590-44c874bf299c | 32 |
| 830557 | KINRIX vaccine 0.5 ML Prefilled Syringe | PSN | 6b5f89e9-1292-4f13-5590-44c874bf299c | 32 |
| 830557 | 0.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/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 [Kinrix] | SBD | 6b5f89e9-1292-4f13-5590-44c874bf299c | 32 |
| 830555 | 0.5 ML acellular pertussis vaccine, inactivated 0.116 MG/ML / diphtheria toxoid vaccine, inactivated 50 UNT/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 | 6b5f89e9-1292-4f13-5590-44c874bf299c | 32 |
| 830555 | acellular pertussis vaccine 0.058 MG / diphtheria toxoid vaccine 25 UNT / 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 | 6b5f89e9-1292-4f13-5590-44c874bf299c | 32 |
| 830555 | diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine (DTaP-IPV generic for Kinrix) 0.5 ML Prefilled Syringe | SY | 6b5f89e9-1292-4f13-5590-44c874bf299c | 32 |
| 830555 | DTaP-IPV 0.5 ML Prefilled Syringe | SY | 6b5f89e9-1292-4f13-5590-44c874bf299c | 32 |
| 830557 | KINRIX DTaP-IPV (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) 0.5 ML Prefilled Syringe | SY | 6b5f89e9-1292-4f13-5590-44c874bf299c | 32 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58160-812-11 | 58160081211 | 10 VIAL in 1 CARTON (58160-812-11) > .5 mL in 1 VIAL (58160-812-01) | 10 vial | 2008-07-09 | 0000-00-00 | No | No | Current |
| 58160-812-43 | 58160081243 | 0.5 mL in 1 SYRINGE | 0.5 ml | Historical | ||||
| 58160-812-52 | 58160081252 | 10 SYRINGE in 1 CARTON (58160-812-52) / .5 mL in 1 SYRINGE (58160-812-43) | 10 syringe | 2008-07-09 | 0000-00-00 | No | No | Current |