Emtricitabine and Tenofovir Disoproxil Fumarate

Product NDC
60505-4202
11-digit product format
605054202
Labeler code
60505
Product ID
60505-4202_49be56f4-6c9e-6ed4-62c0-960547bad59c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
emtricitabine and tenofovir disoproxil fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA208740
Marketing category
ANDA
Marketing start
2021-06-25
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4202-3EA - Each60505-42023ea10547-2f04-476d-84d0-c8cd8e53fe1a12021-07-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-4202-36050542020330 TABLET, FILM COATED in 1 BOTTLE (60505-4202-3) 2021-06-250000-00-00NoNoCurrent