Tenofovir Disoproxil Fumarate

Product NDC
60505-4666
11-digit product format
605054666
Labeler code
60505
Product ID
60505-4666_6b439a4b-5fa1-6b5f-e053-2a91aa0afcbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tenofovir Disoproxil Fumarate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA209498
Marketing category
ANDA
Marketing start
2018-04-26
Marketing end
0000-00-00
Substance
TENOFOVIR DISOPROXIL FUMARATE
Active strength
300 mg/1
Pharmacologic classes
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4666-3EA - Each60505-46661dca9b72-67fc-4b18-ba08-7a8c0888813812018-04-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-4666-36050546660330 TABLET, COATED in 1 BOTTLE, PLASTIC (60505-4666-3) 2018-04-260000-00-00NoNoCurrent