PREVNAR 13 is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Wyeth Pharmaceutical Division Of Wyeth Holdings Llc. The primary component is Streptococcus Pneumoniae Type 1 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 3 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 4 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 5 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 6a Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 6b Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 7f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 9v Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 14 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 18c Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 23f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 19a Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 19f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen.
| Product ID | 0005-1971_0cd635c6-5856-4afd-bb2e-f0b8f65b290d |
| NDC | 0005-1971 |
| Product Type | Vaccine |
| Proprietary Name | PREVNAR 13 |
| Generic Name | Pneumococcal 13-valent Conjugate Vaccine |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2010-03-12 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125324 |
| Labeler Name | Wyeth Pharmaceutical Division of Wyeth Holdings LLC |
| Substance Name | STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN |
| Active Ingredient Strength | 2 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
| Pharm Classes | Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Conjugate [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2010-03-12 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | BLA |
| Application Number | BLA125324 |
| Product Type | VACCINE |
| Marketing Start Date | 2013-02-26 |
| Marketing End Date | 2016-07-28 |
| Marketing Category | BLA |
| Application Number | BLA125324 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2010-03-12 |
| Marketing Category | BLA |
| Application Number | BLA125324 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2010-03-12 |
| Marketing Category | BLA |
| Application Number | BLA125324 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2013-02-26 |
| Ingredient | Strength |
|---|---|
| STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN | 2.2 ug/.5mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0005-1971 | PREVNAR 13 | pneumococcal 13-valent conjugate vaccine |
| 50090-1944 | PREVNAR 13 | pneumococcal 13-valent conjugate vaccine |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PREVNAR 13 88389585 not registered Live/Pending |
Wyeth LLC 2019-04-17 |
![]() PREVNAR 13 77631362 not registered Dead/Abandoned |
Wyeth 2008-12-11 |
![]() PREVNAR 13 77018369 3811235 Live/Registered |
WYETH LLC 2006-10-11 |