Engerix-B NDC 50090-1223

NDC codes

FDA NDC Directory

Product NDC (as listed)50090-1223Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50090-1223Add 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
50090-1223-1	50090122301	1 VIAL, SINGLE-DOSE in 1 POUCH (50090-1223-1) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 28, 2007
50090-1223-2	50090122302	10 VIAL, SINGLE-DOSE in 1 CARTON (50090-1223-2) / 1 mL in 1 VIAL, SINGLE-DOSE (50090-1223-0)Marketed from Mar 28, 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): Engerix-B
Generic name (nonproprietary): hepatitis b vaccine (recombinant)
Active ingredients: Hepatitis b virus subtype adw2 hbsag surface protein antigen — 20 ug/mL
Dosage form: Injection, Suspension
Route: Intramuscular
Labeler: A-S Medication Solutions
Product type: Vaccine
Marketing category: BLA — Biologics License ApplicationApplication BLA 103239
Marketing start: Mar 28, 2007
Listing expires: Dec 31, 2027
Identifiers: Product ID 50090-1223_461dcfb9-3b96-47e1-8061-4d98a6a22f4fSPL ID 461dcfb9-3b96-47e1-8061-4d98a6a22f4f

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

N450090122301 followed by a unit qualifier and the quantity

Package 50090-1223-01. 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 10 ug/.5mL	Injection, SuspensionIntramuscular	GlaxoSmithKline Biologicals SA	58160-820

Engerix-B (hepatitis b vaccine (recombinant)) NDC 50090-1223