Emtricitabine and Tenofovir Disoproxil Fumarate

Product NDC

60219-2094

11-digit product format

602192094

Labeler code

60219

Product ID

60219-2094_051b6cf9-3048-4260-8945-f612791c15fa

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Emtricitabine and Tenofovir Disoproxil Fumarate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Amneal Pharmaceuticals NY LLC

Application

ANDA209721

Marketing category

ANDA

Marketing start

2018-08-26

Marketing end

0000-00-00

Substance

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Active strength

167 mg/1; mg/1

Pharmacologic classes

Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

2021-12-31

Current FDA listing

Historical FDA.report record