{
"NDC": {
"NDCCode": "58160-815-52",
"PackageDescription": "10 SYRINGE in 1 CARTON (58160-815-52) / 1 mL in 1 SYRINGE (58160-815-43) ",
"NDC11Code": "58160-0815-52",
"ProductNDC": "58160-815",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Twinrix",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Hepatitis A And Hepatitis B (recombinant) Vaccine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20070607",
"EndMarketingDate": null,
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103850",
"LabelerName": "GlaxoSmithKline Biologicals SA",
"SubstanceName": "HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN",
"StrengthNumber": "720; 20",
"StrengthUnit": "[iU]/mL; ug/mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Hepatitis A Vaccines [CS], Inactivated Hepatitis A Virus Vaccine [EPC], Vaccines, Inactivated [CS]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070607",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}