Engerix-B NDC 58160-820

NDC codes

FDA NDC Directory

Product NDC (as listed)58160-820Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58160-0820Add 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 NDC	11-digit (billing)	Package	Copy
58160-820-52	58160082052	10 SYRINGE in 1 CARTON (58160-820-52) / .5 mL in 1 SYRINGE (58160-820-43)Marketed from Apr 25, 2007

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): Engerix-B
Generic name (nonproprietary): hepatitis b vaccine (recombinant)
Active ingredients: Hepatitis b virus subtype adw2 hbsag surface protein antigen — 10 ug/.5mL
Dosage form: Injection, Suspension
Route: Intramuscular
Labeler: GlaxoSmithKline Biologicals SA
Product type: Vaccine
Marketing category: BLA — Biologics License ApplicationApplication BLA 103239
Marketing start: Apr 25, 2007
Listing expires: Dec 31, 2027
Identifiers: Product ID 58160-820_b3c5a55f-bf21-4cea-9fce-715face6eeb0SPL ID b3c5a55f-bf21-4cea-9fce-715face6eeb0

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

N458160082052 followed by a unit qualifier and the quantity

Package 58160-0820-52. 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 103239

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

FDA NDC Directory listings under BLA 103239
Product	Strength	Form · route	Labeler	Product NDC
Engerix-Bhepatitis b vaccine (recombinant)	Hepatitis b virus subtype adw2 hbsag surface protein antigen 20 ug/mL	Injection, SuspensionIntramuscular	GlaxoSmithKline Biologicals SA	58160-821
Engerix-Bhepatitis b vaccine (recombinant)	Hepatitis b virus subtype adw2 hbsag surface protein antigen 20 ug/mL	Injection, SuspensionIntramuscular	A-S Medication Solutions	50090-1223

Engerix-B (hepatitis b vaccine (recombinant)) NDC 58160-820