NDC codes

FDA NDC Directory
Product NDC (as listed)50090-3781Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-3781Add 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
50090-3781-05009037810010 SYRINGE in 1 CARTON (50090-3781-0) / .5 mL in 1 SYRINGE (50090-3781-1)Marketed from Feb 16, 2007

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Havrix
Generic name (nonproprietary)
hepatitis a vaccine
Active ingredients
Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated)720 [iU]/.5mL
Dosage form
Injection, Suspension
Route
Intramuscular
Product type
Vaccine
Marketing category
BLA — Biologics License ApplicationApplication BLA 103475
Marketing start
Listing expires
Other FDA classes
Actively Acquired Immunity (Physiologic effect)Hepatitis A Vaccines (Chemical structure)Inactivated (Chemical structure)
Identifiers
Product ID 50090-3781_e0a78abf-4f24-4c13-ac00-6c193441275dSPL ID e0a78abf-4f24-4c13-ac00-6c193441275d
Pharmacologic class
Inactivated Hepatitis A Virus 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

N450090378100 followed by a unit qualifier and the quantity

Package 50090-3781-00. 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 103475

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

FDA NDC Directory listings under BLA 103475
ProductStrengthForm · routeLabelerProduct NDC
Havrixhepatitis a vaccineHepatitis a virus strain hm175 antigen (Formaldehyde inactivated) 1440 [iU]/mLInjection, SuspensionIntramuscularGlaxoSmithKline Biologicals SA58160-826
Havrixhepatitis a vaccineHepatitis a virus strain hm175 antigen (Formaldehyde inactivated) 720 [iU]/.5mLInjection, SuspensionIntramuscularGlaxoSmithKline Biologicals SA58160-825
Havrixhepatitis a vaccineHepatitis a virus strain hm175 antigen (Formaldehyde inactivated) 1440 [iU]/mLInjection, SuspensionIntramuscularA-S Medication Solutions50090-1502

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Havrix (hepatitis a vaccine) NDC 50090-3781 | Med-Code