Tenofovir Disoproxil Fumarate

Product NDC
63629-9729
11-digit product format
636299729
Labeler code
63629
Product ID
63629-9729_d16dde3e-a659-4acf-8f85-b18b0f0dbc9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tenofovir Disoproxil Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090636
Marketing category
ANDA
Marketing start
2018-01-26
Substance
TENOFOVIR DISOPROXIL FUMARATE
Active strength
300 mg/1
Pharmacologic classes
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
OTT9J7900ITENOFOVIR DISOPROXIL FUMARATE202138-50-9TENOFOVIR DISOPROXIL FUMARATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-9729-16362997290130 TABLET, FILM COATED in 1 BOTTLE (63629-9729-1) 2023-08-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Tenofovir Disoproxil FumarateBryant Ranch Prepack2023-08-11HUMAN PRESCRIPTION DRUG LABEL100