"32228-004-01" National Drug Code (NDC)

NDC Code	32228-004-01
Package Description	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (32228-004-01)
Product NDC	32228-004
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Temixys
Non-Proprietary Name	Lamivudine And Tenofovir Disoproxil Fumarate
Dosage Form	TABLET, FILM COATED
Usage	ORAL
Start Marketing Date	20181116
Marketing Category Name	NDA
Application Number	NDA211284
Manufacturer	CELLTRION, INC.
Substance Name	LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Strength	300; 300
Strength Unit	mg/1; mg/1
Pharmacy Classes	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]