"58160-815-34" National Drug Code (NDC)

Twinrix 1 SYRINGE in 1 CARTON (58160-815-34) > 1 mL in 1 SYRINGE (58160-815-05)
(GlaxoSmithKline Biologicals SA)

NDC Code58160-815-34
Package Description1 SYRINGE in 1 CARTON (58160-815-34) > 1 mL in 1 SYRINGE (58160-815-05)
Product NDC58160-815
Product Type NameVACCINE
Proprietary NameTwinrix
Non-Proprietary NameHepatitis A And Hepatitis B (recombinant) Vaccine
Dosage FormINJECTION, SUSPENSION
UsageINTRAMUSCULAR
Start Marketing Date20070607
Marketing Category NameBLA
Application NumberBLA103850
ManufacturerGlaxoSmithKline Biologicals SA
Substance NameHEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN
Strength720; 20
Strength Unit[iU]/mL; ug/mL
Pharmacy ClassesInactivated Hepatitis A Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis A Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient]

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