Penmenvy Kit
NDC Package 58160-757-15
Package Information
Penmenvy (meningococcal (groups a, b, c, w and y)) kits is pENMENVY is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals 10 through 25 years of age. This formulation utilizes a kit delivery system. Marketed by Glaxosmithkline Biologicals Sa, this product is identified by NDC 58160-757 and is authorized under FDA application BLA125819.
Identification & Billing
- RxCUI: 2705460 - Meningococcal (Groups A,B,C,Y and W-135) Polysaccharide Vaccine 0.5 ML Injection
- RxCUI: 2705460 - 0.5 ML Neisseria meningitidis serogroup A oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup B recombinant FHBP fusion protein antigen 0.1 MG/ML / Neisseria meningitidis serogroup B recombinant NADA fusion protein antigen 0.1 MG/ML / Neisseria meningitidis serogroup B recombinant NHBA fusion protein antigen 0.1 MG/ML / Neisseria meningitidis serogroup B strain NZ98/254 outer membrane vesicle 0.05 MG/ML / Neisseria meningitidis serogroup C oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup W-135 oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup Y oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML Injection
- RxCUI: 2705460 - Neisseria meningitidis serogroup A oligosaccharide diphtheria CRM197 protein conjugate vaccine 10 MCG / Neisseria meningitidis serogroup B recombinant NHBA fusion protein antigen 50 MCG / Neisseria meningitidis serogroup B recombinant FHBP fusion protein antigen 50 MCG / Neisseria meningitidis serogroup B recombinant NADA fusion protein antigen 50 MCG / Neisseria meningitidis serogroup B strain NZ98/254 outer membrane vesicle 25 MCG / Neisseria meningitidis serogroup C oligosaccharide diphtheria CRM197 protein conjugate vaccine 5 MCG / Neisseria meningitidis serogroup W-135 oligosaccharide diphtheria CRM197 protein conjugate vaccine 5 MCG / Neisseria meningitidis serogroup Y oligosaccharide diphtheria CRM197 protein conjugate vaccine 5 MCG per 0.5 ML Injection
- RxCUI: 2705467 - PENMENVY vaccine 0.5 ML Injection
- RxCUI: 2705467 - 0.5 ML Neisseria meningitidis serogroup A oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup B recombinant FHBP fusion protein antigen 0.1 MG/ML / Neisseria meningitidis serogroup B recombinant NADA fusion protein antigen 0.1 MG/ML / Neisseria meningitidis serogroup B recombinant NHBA fusion protein antigen 0.1 MG/ML / Neisseria meningitidis serogroup B strain NZ98/254 outer membrane vesicle 0.05 MG/ML / Neisseria meningitidis serogroup C oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup W-135 oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup Y oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML Injection [Penmenvy]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 58160 - Glaxosmithkline Biologicals Sa
- 58160-757 - Penmenvy
- 58160-757-15 - 1 KIT in 1 CARTON * .5 mL in 1 VIAL (58160-730-03) * .5 mL in 1 SYRINGE (58160-750-03)
- 58160-757 - Penmenvy
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 58160-757-15 identifies a specific commercial package of 1 kit in 1 carton * .5 ml in 1 vial (58160-730-03) * .5 ml in 1 syringe (58160-750-03) of Penmenvy, a vaccine label labeled by Glaxosmithkline Biologicals Sa. This kit is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Glaxosmithkline Biologicals Sa on February 14, 2025. The current certification is valid through December 31, 2027.
How is this Glaxosmithkline Biologicals Sa product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 58160075715. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
