RANITIDINE
Ranitidine Tablets, USP
Approved
Approval ID
d5962f4c-1cbc-4034-b171-9a35fc75b546
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 2, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
RANITIDINE
PRODUCT DETAILS
NDC Product Code16590-381
Application NumberANDA077824
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 3, 2012
Generic NameRANITIDINE
INGREDIENTS (9)
RANITIDINE HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: BK76465IHM
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
RANITIDINE
PRODUCT DETAILS
NDC Product Code16590-200
Application NumberANDA077824
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 3, 2012
Generic NameRANITIDINE
INGREDIENTS (10)
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
RANITIDINE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: BK76465IHM
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT