Emtricitabine and Tenofovir Disoproxil Fumarate

Product NDC
71335-1844
11-digit product format
713351844
Labeler code
71335
Product ID
71335-1844_2ec19e4e-6ab0-44d3-ba36-1744a9197a85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Emtricitabine and Tenofovir Disoproxil Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090513
Marketing category
ANDA
Marketing start
2021-03-10
Marketing end
0000-00-00
Substance
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength
200 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
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1844-17133518440130 TABLET, FILM COATED in 1 BOTTLE (71335-1844-1) 2021-04-290000-00-00NoNoCurrent
71335-1844-2713351844023 TABLET, FILM COATED in 1 BOTTLE (71335-1844-2) 2021-04-290000-00-00NoNoCurrent