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HEPLISAV-B

NDC 43528-003, Hepatitis B Vaccine (Recombinant) Adjuvanted, injection, solution, from Dynavax Technologies Corporation.

Product NDC
43528-003
Status
Listed
Labeler
Dynavax Technologies Corporation
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Product type
VACCINE
Marketing category
BLA
Application
BLA125428
DEA schedule
None
Request
curl https://api.healthcare.dev/v1/drugs/ndc/43528-003 \
  -H "Authorization: Bearer $HDEV_API_KEY"

Product

Active ingredients and packages

Active ingredients

  • HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN20 ug/.5mL

Pharmacologic classes

Actively Acquired Immunity [PE]; Hepatitis B Vaccines [CS]; Inactivated Hepatitis B Virus Vaccine [EPC]; Vaccines, Inactivated [CS]

Package NDCNDC-11Package
43528-003-05435280003055 SYRINGE in 1 CARTON (43528-003-05) / .5 mL in 1 SYRINGE (43528-003-01)

Linked data

RxNorm, label and prices

RxNorm concepts

Related lookups

No FDA label, Medicare Part B payment limit or NADAC price is linked to this product.

Use it

Look up 43528-003 from code or an agent

curl
curl https://api.healthcare.dev/v1/drugs/ndc/43528-003 \
  -H "Authorization: Bearer $HDEV_API_KEY"
MCP prompt
Using the healthcare.dev MCP server, look up NDC 43528-003. Tell me the product, its labeler, dosage form and route, its packages, and the RxNorm concepts it maps to.

Source: FDA, release 2026-10-23. Public domain. Reference data, not medical advice.