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NDC 43528-0003-05 HEPLISAV-B 20 ug/.5mL Details
HEPLISAV-B 20 ug/.5mL
HEPLISAV-B is a INTRAMUSCULAR INJECTION, SOLUTION in the VACCINE category. It is labeled and distributed by Dynavax Technologies Corporation. The primary component is HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN.
MedlinePlus Drug Summary
Why get vaccinated against hepatitis B? Hepatitis B vaccine can prevent hepatitis B. Hepatitis B is a liver disease that can cause mild illness lasting a few weeks, or it can lead to a serious, lifelong illness. Acute hepatitis B virus infection is a short-term illness that can lead to fever, fatigue, loss of appetite, nausea, vomiting, jaundice (yellow skin or eyes, dark urine, clay-colored bowel movements), and pain in the muscles, joints, and stomach. Chronic hepatitis B virus infection is a long-term illness that occurs when the hepatitis B virus remains in a person's body. Most people who go on to develop chronic hepatitis B do not have symptoms, but it is still very serious and can lead to liver damage (cirrhosis), liver cancer, and death. Chronically infected people can spread hepatitis B virus to others, even if they do not feel or look sick themselves. Hepatitis B is spread when blood, semen, or other body fluid infected with the hepatitis B virus enters the body of a person who is not infected. People can become infected with the virus through: Birth (if a pregnant person has hepatitis B, their baby can become infected) Sharing items such as razors or toothbrushes with an infected person Contact with the blood or open sores of an infected person Sex with an infected partner Sharing needles, syringes, or other drug-injection equipment Exposure to blood from needlesticks or other sharp instruments Most people who are vaccinated with hepatitis B vaccine are immune for life..
Related Packages: 43528-0003-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hepatitis B Vaccine
Product Information
NDC | 43528-0003 |
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Product ID | 43528-003_f698a0e4-1e23-47f3-aee5-2d6c54131e5a |
Associated GPIs | 1710001030E520 |
GCN Sequence Number | 078645 |
GCN Sequence Number Description | hepatitis B vaccine/CpG1018/PF SYRINGE 20 MCG/0.5 INTRAMUSC |
HIC3 | W7B |
HIC3 Description | VIRAL/TUMORIGENIC VACCINES |
GCN | 45012 |
HICL Sequence Number | 044645 |
HICL Sequence Number Description | HEPATITIS B VACCINE RECOMBINANT/VACCINE ADJUVANT CPG 1018/PF |
Brand/Generic | Brand |
Proprietary Name | HEPLISAV-B |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Hepatitis B Vaccine (Recombinant) Adjuvanted |
Product Type | VACCINE |
Dosage Form | INJECTION, SOLUTION |
Route | INTRAMUSCULAR |
Active Ingredient Strength | 20 |
Active Ingredient Units | ug/.5mL |
Substance Name | HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN |
Labeler Name | Dynavax Technologies Corporation |
Pharmaceutical Class | Actively Acquired Immunity [PE], Hepatitis B Vaccines [CS], Inactivated Hepatitis B Virus Vaccine [EPC], Vaccines, Inactivated [CS] |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA125428 |
Listing Certified Through | 2024-12-31 |
Package
NDC 43528-0003-05 (43528000305)
NDC Package Code | 43528-003-05 |
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Billing NDC | 43528000305 |
Package | 5 SYRINGE in 1 CARTON (43528-003-05) / .5 mL in 1 SYRINGE (43528-003-01) |
Marketing Start Date | 2018-01-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |