TENOFOVIR DISOPROXIL FUMARATE
These highlights do not include all the information needed to use TENOFOVIR DISOPROXIL FUMARATE TABLETS safely and effectively. See full prescribing information for TENOFOVIR DISOPROXIL FUMARATE TABLETS. TENOFOVIR DISOPROXIL FUMARATE tablets, for oral useInitial U.S. Approval Date: 2001
Approved
Approval ID
14a8db19-3c49-4faa-b572-850176f1b8f1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2019
Manufacturers
FDA
DOH CENTRAL PHARMACY
DUNS: 829348114
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tenofovir disoproxil fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-1128
Application NumberANDA090742
Product Classification
M
Marketing Category
C73584
G
Generic Name
tenofovir disoproxil fumarate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2019
FDA Product Classification
INGREDIENTS (9)
TENOFOVIR DISOPROXIL FUMARATEActive
Quantity: 300 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT