Ranitidine
Ranitidine Tablets USP, 150 mg and 300 mg
Approved
Approval ID
e24b34ec-d779-4c99-a9e9-0a3bdee39f0c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 7, 2020
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code71335-1621
Application NumberANDA078542
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 7, 2018
Generic NameRanitidine
INGREDIENTS (9)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
RANITIDINE HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: BK76465IHM
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Ranitidine
PRODUCT DETAILS
NDC Product Code71335-1327
Application NumberANDA078542
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 7, 2018
Generic NameRanitidine
INGREDIENTS (9)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
RANITIDINE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: BK76465IHM
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT