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NDC 00005-1971-05 PREVNAR 13 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 4.4; 2.2; 2.2 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 Details
PREVNAR 13 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 4.4; 2.2; 2.2 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
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 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCH.
MedlinePlus Drug Summary
Why get vaccinated? Pneumococcal conjugate vaccine (PCV13) can prevent pneumococcal disease. Pneumococcal disease refers to any illness caused by pneumococcal bacteria. These bacteria can cause many types of illnesses, including pneumonia, which is an infection of the lungs. Pneumococcal bacteria are one of the most common causes of pneumonia. Besides pneumonia, pneumococcal bacteria can also cause: Ear infections Sinus infections Meningitis (infection of the tissue covering the brain and spinal cord) Bacteremia (infection of the blood) Anyone can get pneumococcal disease, but children under 2 years of age, people with certain medical conditions, adults 65 years and older, and cigarette smokers are at the highest risk. Most pneumococcal infections are mild. However, some can result in long-term problems, such as brain damage or hearing loss. Meningitis, bacteremia, and pneumonia caused by pneumococcal disease can be fatal.
Related Packages: 00005-1971-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pneumococcal Conjugate Vaccine (PCV13)
Product Information
| NDC | 00005-1971 |
|---|---|
| Product ID | 0005-1971_c6d01d5e-3968-4485-8eee-e2ffe73bbffe |
| Associated GPIs | 17200065301800 |
| GCN Sequence Number | 066068 |
| GCN Sequence Number Description | pneumoc 13-val conj-Dip crm/PF SYRINGE 0.5 ML INTRAMUSC |
| HIC3 | W7L |
| HIC3 Description | GRAM POSITIVE COCCI VACCINES |
| GCN | 28232 |
| HICL Sequence Number | 036856 |
| HICL Sequence Number Description | PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE (DIPHTHERIA CRM)/PF |
| Brand/Generic | Brand |
| Proprietary Name | PREVNAR 13 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | pneumococcal 13-valent conjugate vaccine |
| Product Type | VACCINE |
| Dosage Form | INJECTION, SUSPENSION |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 4.4; 2.2; 2.2 |
| Active Ingredient Units | 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 |
| Substance Name | STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCH |
| Labeler Name | Wyeth Pharmaceutical Division of Wyeth Holdings LLC |
| Pharmaceutical Class | 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 Immuni |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125324 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00005-1971-05 (00005197105)
| NDC Package Code | 0005-1971-05 |
|---|---|
| Billing NDC | 00005197105 |
| Package | 1 SYRINGE in 1 CARTON (0005-1971-05) / .5 mL in 1 SYRINGE (0005-1971-01) |
| Marketing Start Date | 2010-03-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |