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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 use Initial U.S. Approval: 2001

Approved
Approval ID

b43a3cae-059e-4af8-8fcf-07a597e57f0d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 27, 2022

Manufacturers
FDA

Qilu Pharmaceutical Co., Ltd.

DUNS: 653878256

Products 3

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 Code67184-0521
Application NumberANDA209498
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tenofovir Disoproxil Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2022
FDA Product Classification

INGREDIENTS (10)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TENOFOVIR DISOPROXIL FUMARATEActive
Quantity: 300 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Tenofovir Disoproxil Fumarate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67184-0519
Application NumberANDA209498
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tenofovir Disoproxil Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2022
FDA Product Classification

INGREDIENTS (9)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TENOFOVIR DISOPROXIL FUMARATEActive
Quantity: 200 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB

Tenofovir Disoproxil Fumarate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67184-0520
Application NumberANDA209498
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tenofovir Disoproxil Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2022
FDA Product Classification

INGREDIENTS (9)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
TENOFOVIR DISOPROXIL FUMARATEActive
Quantity: 250 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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Tenofovir Disoproxil Fumarate - FDA Drug Approval Details