NDC codes

FDA NDC Directory
Product NDC (as listed)58160-827Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58160-0827Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
58160-827-305816008273010 VIAL in 1 CARTON (58160-827-30) / .5 mL in 1 VIAL (58160-827-03)Marketed from Dec 9, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Menveo
Generic name (nonproprietary)
meningococcal (groups a, c, y and w-135) oligosaccharide diphtheria crm197 conjugate vaccine
Active ingredients
Neisseria meningitidis group a capsular oligosaccharide diphtheria crm197 protein conjugate antigen10 ug/.5mLNeisseria meningitidis group c capsular oligosaccharide diphtheria crm197 protein conjugate antigen5 ug/.5mLNeisseria meningitidis group w-135 capsular oligosaccharide diphtheria crm197 protein conjugate antigen5 ug/.5mLNeisseria meningitidis group y capsular oligosaccharide diphtheria crm197 protein conjugate antigen5 ug/.5mL
Dosage form
Injection, Solution
Route
Intramuscular
Product type
Vaccine
Marketing category
BLA — Biologics License ApplicationApplication BLA 125300
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)Meningococcal Vaccines (Chemical structure)Meningococcal Vaccines (Chemical structure)Meningococcal Vaccines (Chemical structure)Meningococcal Vaccines (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)
Identifiers
Product ID 58160-827_ffd9ae2b-caa1-4753-86f2-fc7a8180ff79SPL ID ffd9ae2b-caa1-4753-86f2-fc7a8180ff79
Pharmacologic class
Inactivated Meningococcal 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.

How CPT relates to drug billing

NDC on a medical claim

N458160082730 followed by a unit qualifier and the quantity

Package 58160-0827-30. 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.

Other NDCs under BLA 125300

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 125300
ProductStrengthForm · routeLabelerProduct NDC
Menveomeningococcal (groups a, c, y and w-135) oligosaccharide diphtheria crm197 conjugate vaccineKitGlaxoSmithKline Biologicals SA58160-955

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