What is NDC 43528-003?

43528-003 is the product NDC for Heplisav-B, Hepatitis b virus subtype adw hbsag surface protein antigen 20 ug/.5mL injection, solution, listed with the FDA by Dynavax Technologies Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Heplisav-B (Hepatitis B Vaccine (Recombinant) Adjuvanted).

What is the active ingredient?

Hepatitis b virus subtype adw hbsag surface protein antigen.

Dynavax Technologies Corporation, NDC labeler code 43528. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Heplisav-B?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Heplisav-B NDC 43528-003 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43528-003Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43528-0003Add 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
43528-003-05	4352800030543528000305	5 SYRINGE in 1 CARTON (43528-003-05) / .5 mL in 1 SYRINGE (43528-003-01)Marketed from Jan 1, 2018

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): Heplisav-B
Generic name (nonproprietary): hepatitis b vaccine (recombinant) adjuvanted
Active ingredients: Hepatitis b virus subtype adw hbsag surface protein antigen — 20 ug/.5mL
Dosage form: Injection, Solution
Route: Intramuscular
Labeler: Dynavax Technologies CorporationNDC labeler code 43528
Product type: Vaccine
Marketing category: BLA — Biologics License ApplicationApplication BLA 125428
Marketing start: Jan 1, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Actively Acquired Immunity (Physiologic effect)Hepatitis B Vaccines (Chemical structure)Inactivated (Chemical structure)
Identifiers: Product ID 43528-003_4b308f87-c35b-9d96-e063-6294a90aff8eSPL ID 4b308f87-c35b-9d96-e063-6294a90aff8e
Pharmacologic class: Inactivated Hepatitis B 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

N443528000305 followed by a unit qualifier and the quantity

Package 43528-0003-05. 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.

About NDC 43528-003

What is NDC 43528-003?: 43528-003 is the product NDC for Heplisav-B, Hepatitis b virus subtype adw hbsag surface protein antigen 20 ug/.5mL injection, solution, listed with the FDA by Dynavax Technologies Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Heplisav-B (Hepatitis B Vaccine (Recombinant) Adjuvanted).
What is the active ingredient?: Hepatitis b virus subtype adw hbsag surface protein antigen.
Who is the labeler?: Dynavax Technologies Corporation, NDC labeler code 43528. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Heplisav-B?: 2 other product NDCs are listed under this name. See all Heplisav-B NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Heplisav-B NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Heplisav-Bhepatitis b vaccine (recombinant) adjuvanted	Hepatitis b virus subtype adw hbsag surface protein antigen 20 ug/.5mL	Injection, SolutionIntramuscular	A-S Medication Solutions	50090-4526	50090-4526-00
Heplisav-Bhepatitis b vaccine (recombinant) adjuvanted	Hepatitis b virus subtype adw hbsag surface protein antigen 20 ug/.5mL	Injection, SolutionIntramuscular	Bamboo US BidCo LLC	83703-048	83703-0048-05

Other NDCs under BLA 125428

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

FDA NDC Directory listings under BLA 125428
Product	Strength	Form · route	Labeler	Product NDC
Heplisav-Bhepatitis b vaccine (recombinant) adjuvanted	Hepatitis b virus subtype adw hbsag surface protein antigen 20 ug/.5mL	Injection, SolutionIntramuscular	A-S Medication Solutions	50090-4526
Heplisav-Bhepatitis b vaccine (recombinant) adjuvanted	Hepatitis b virus subtype adw hbsag surface protein antigen 20 ug/.5mL	Injection, SolutionIntramuscular	Bamboo US BidCo LLC	83703-048