Vaccine · BLA
Capvaxive (pneumococcal 21-valent conjugate vaccine) NDC 0006-4347
Streptococcus pneumoniae type 3 capsular polysaccharide diphtheria crm197 protein conjugate antigen 4 ug/.5mL + 21 more ingredients · Injection, Solution · Intramuscular · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0006-4347-01 | 00006434701 | 1 SYRINGE in 1 CARTON (0006-4347-01) / .5 mL in 1 SYRINGE (0006-4347-99)Marketed from Jun 17, 2024 | |
| 0006-4347-02 | 00006434702 | 10 SYRINGE in 1 CARTON (0006-4347-02) / .5 mL in 1 SYRINGE (0006-4347-99)Marketed from Jun 17, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Capvaxive
- Generic name (nonproprietary)
- pneumococcal 21-valent conjugate vaccine
- Active ingredients
- Streptococcus pneumoniae type 3 capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 6a capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 7f capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 8 capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 9n capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 10a capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 11a capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 12f capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 15a capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type deoac15b capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 16f capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 17f capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 19a capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 20a capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 22f capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 23a capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 23b capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 24f capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 31 capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 33f capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLStreptococcus pneumoniae type 35b capsular polysaccharide diphtheria crm197 protein conjugate antigen — 4 ug/.5mLCorynebacterium diphtheriae crm197 protein — 65 ug/.5mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular
- Labeler
- Merck Sharp & Dohme LLC
- Product type
- Vaccine
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125814
- Marketing start
- Listing expires
- Other FDA classes
- Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Pneumococcal Vaccines (Chemical structure)Pneumococcal Vaccines (Chemical structure)Pneumococcal Vaccines (Chemical structure)Pneumococcal Vaccines (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)
- Identifiers
- Product ID 0006-4347_6de138f0-9937-47cb-ae68-676516dab2e2SPL ID 6de138f0-9937-47cb-ae68-676516dab2e2
- Pharmacologic class
- Inactivated Pneumococcal Vaccine
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Immunization administration (CPT 90460–90474)
Giving a vaccine is reported separately from the vaccine product code, with an immunization administration code. Which code applies depends on the patient's age, the route and whether counselling was provided.
- NDC on a medical claim
N400006434701followed by a unit qualifier and the quantityPackage 00006-4347-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
The FDA listing for this product does not reference a label (SPL) set.