Emtricitabine and Tenofovir Disoproxil Fumarate

Product NDC
42291-439
11-digit product format
422910439
Labeler code
42291
Product ID
42291-439_ec6b1bce-09cb-23a0-e053-2995a90ad50f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Emtricitabine and Tenofovir Disoproxil Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA209721
Marketing category
ANDA
Marketing start
2021-03-30
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-439-30EA - Each42291-4395b87ff6d-37ca-4ee0-9dbe-9e2045d1e07412021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-439EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [AVKARE]3Legacy NDC20240110_bec65789-2f4b-134d-e053-2a95a90ab597.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-439-304229104393030 TABLET, FILM COATED in 1 BOTTLE (42291-439-30) 2021-03-300000-00-00NoNoCurrent