NDC 58160-757-15 VACCINE

Drug Status:  Active

Proprietary Name: Penmenvy

Drug Overview

The NDC Code 58160-757-15 is assigned to “Penmenvy ” (also known as: “Meningococcal (groups A, B, C, W And Y)”), a vaccine labeled by “GlaxoSmithKline Biologicals SA”. The product's dosage form is kit.

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Drug Information
NDC Package Code	58160-757-15
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Product NDC	58160-757
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
11 Digit NDC Code	58160-0757-15
	It should be noted that many NDCs are displayed on drug packaging in a 10-digit format. Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs from a 10-digit to 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.
Proprietary Name	Penmenvy
	Also known as the trade name. It is the name of the product chosen by the labeler.
Non Proprietary Name	Meningococcal (groups A B C W And Y)
	Sometimes called the generic name, this is usually the active ingredient(s) of the product.
Product Type Name	VACCINE
	Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Labeler Name	GlaxoSmithKline Biologicals SA
	Name of Company corresponding to the labeler code segment of the ProductNDC.
Status	Active
	Possible status values: Active Active NDC Code Deprecated Deprecated NDC Code Unfinished (Unapproved) The following status describes submitted unfinished drugs, including the marketing categories of Active Pharmaceutical Ingredient (API), Drug for Further Processing, Bulk for Human Drug Compounding, and Bulk for Animal Drug Compounding. FDA does not review and approve unfinished products. Therefore, all products having "unfinished" status are considered unapproved.
Description	PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine) is a sterile injectable suspension for intramuscular use. The vaccine is supplied as one vial of Lyophilized MenACWY Component which is reconstituted at the time of use with the accompanying prefilled syringe of MenB Component. The Lyophilized MenACWY Component contains N. meningitidis serogroups A, C, W, and Y oligosaccharides conjugated individually to Corynebacterium diphtheriae CRM197 protein. The polysaccharides are produced by bacterial fermentation of N. meningitidis serogroups A, C, W, or Y. N. meningitidis serogroup A, C, W, and Y strains are each cultured and grown on Franz Complete medium and treated with formaldehyde. MenA, MenW, and MenY polysaccharides are purified by several steps, including extraction, filtration, and precipitation. MenC polysaccharide is purified by a combination of extraction, chromatography, and precipitation steps. The protein carrier (CRM197) is produced by bacterial fermentation and is purified by a series of chromatography and ultrafiltration steps. The C. diphtheriae is cultured and grown on CY medium containing yeast extracts and amino acids. The oligosaccharides are prepared for conjugation from the purified polysaccharides which are processed by hydrolysis, sizing, and reductive amination. After activation, each oligosaccharide is covalently linked to the CRM197 protein. The resulting glycoconjugates are purified to yield the four drug substances, which are formulated with sucrose and phosphate and lyophilized to form the Lyophilized MenACWY Component. The Lyophilized MenACWY Component is a white to off‑white lyophilized cake. The MenB Component contains recombinant N. meningitidis proteins Neisseria adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), and Outer Membrane Vesicles (OMV). The NadA component is a fragment of the full‑length protein derived from N. meningitidis strain 2996 (peptide 8 variant 2/3).2 The NHBA component is a recombinant fusion protein comprised of NHBA (peptide 2)2 and accessory protein 953 derived from N. meningitidis strains NZ98/254 and 2996, respectively. The fHbp component is a recombinant fusion protein comprised of fHbp (variant 1.1)2 and the accessory protein 936 derived from N. meningitidis strains MC58 and 2996, respectively. These 3 recombinant proteins are individually produced in Escherichia coli and purified through a series of column chromatography steps. The OMV antigenic component is produced by fermentation of N. meningitidis strain NZ98/254 (expressing outer membrane protein Porin A [PorA] serosubtype P1.4),3 followed by inactivation of the bacteria by deoxycholate, which also mediates vesicle formation. The antigens are adsorbed onto aluminum hydroxide. The MenB Component is a white opalescent suspension. After reconstitution, each approximately 0.5‑mL dose contains 10 mcg MenA oligosaccharide; 5 mcg of each of MenC, MenW, and MenY oligosaccharides; 25.9 to 64.1 mcg CRM197 protein; 50 mcg each of recombinant proteins NadA, NHBA, and fHbp; and 25 mcg of OMV. Each dose also contains 1.5 mg aluminum hydroxide (0.5 mg of Al3+), 3.125 mg sodium chloride, 0.776 mg histidine, 22.5 mg sucrose, and ≤0.7 mg potassium phosphate salts. Each dose contains less than 0.01 mcg kanamycin (by calculation). Residual formaldehyde per dose is estimated to be not more than 0.30 mcg. After reconstitution, PENMENVY is a white opalescent suspension. The tip cap and rubber plunger of the prefilled syringe and the stopper of the vial are not made with natural rubber latex. PENMENVY does not contain preservatives.
	General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.
Indication And Usage	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.
	A statement of each of the drug productÕs indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition.This field may also describe any relevant limitations of use.

Route & Dosage
Dosage Form Name	KIT
	The translation of the DosageForm Code submitted by the firm. The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Route Name	N/S (NOT SPECIFIED)
	The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Pharmaceutical Classes	N/S (NOT SPECIFIED)
	These are the reported pharmaceutical class categories corresponding to the SubstanceNames listed above.

Substance & Strength
Substance Name	N/S (NOT SPECIFIED)
	This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Drug Package Information
NDC Package Code	58160-757-15
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Package Description	1 KIT IN 1 CARTON (58160-757-15) * .5 ML IN 1 VIAL (58160-730-03) * .5 ML IN 1 SYRINGE (58160-750-03)
	A description of the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. For example: 4 BOTTLES in 1 CARTON/100 TABLETS in 1 BOTTLE.
Sample Package	N
	Defines whether given package serves sample purposes.
Package NDC Exclude Flag	N
	This indicates whether the package has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.
Package Start Marketing Date	20250214
	This is the date that the labeler indicates was the start of its marketing of the drug package.
Package End Marketing Date	N/S (NOT SPECIFIED)
	This is the date the package will no longer be available on the market. If a package is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Packages that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Packages with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Product Application & Marketing Information
Product NDC	58160-757
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Application Number	BLA125819
	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Marketing Category Name	BLA
	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Listing Record Certified Through	20261231
	This is the date when the listing record will expire if not updated or certified by the firm.
Product Marketing Start Date	20250214
	This is the date that the labeler indicates was the start of its marketing of the drug product.
Product Marketing End Date	N/S (NOT SPECIFIED)
	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Product NDC Exclude Flag	N
	This indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.

Tracking Information
Last Update Date	2025-08-11
	The date that a record was last updated or changed.