Ranitidine
Ranitidine Tablets USP, 300 mg
Approved
Approval ID
75b0e4f3-57df-44d4-88cc-e5141b458e71
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 23, 2018
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ranitidine
PRODUCT DETAILS
NDC Product Code53217-372
Application NumberANDA078542
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 23, 2018
Generic NameRanitidine
INGREDIENTS (9)
RANITIDINE HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: BK76465IHM
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT