Truvada

Product NDC
70518-0097
11-digit product format
705180097
Labeler code
70518
Product ID
70518-0097_df38be31-b767-7143-e053-2995a90a05c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
emtricitabine and tenofovir disoproxil fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA021752
Marketing category
NDA
Marketing start
2016-12-30
Marketing end
0000-00-00
Substance
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength
200 mg/1; mg/1
Pharmacologic classes
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0097-07051800970030 TABLET, FILM COATED in 1 BLISTER PACK (70518-0097-0) 2016-12-300000-00-00NoNoCurrent
70518-0097-1705180097013 TABLET, FILM COATED in 1 BLISTER PACK (70518-0097-1) 2017-02-220000-00-00NoNoCurrent