LAMIVUDINE
These highlights do not include all the information needed to use lamivudine tablets safely and effectively. See full prescribing information for lamivudine tablets. Lamivudine Tablets 150 mg and 300 mg, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
26182670-f400-49b8-92e7-f0124920af78
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 12, 2013
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lamivudine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0844
Application NumberANDA091606
Product Classification
M
Marketing Category
C73584
G
Generic Name
lamivudine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2013
FDA Product Classification
INGREDIENTS (10)
LAMIVUDINEActive
Quantity: 300 mg in 1 1
Code: 2T8Q726O95
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
lamivudine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0843
Application NumberANDA091606
Product Classification
M
Marketing Category
C73584
G
Generic Name
lamivudine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2013
FDA Product Classification
INGREDIENTS (9)
LAMIVUDINEActive
Quantity: 150 mg in 1 1
Code: 2T8Q726O95
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT