Ranitidine
648 Ranitidine 150 mg 649 Ranitidine 300 mg Ranitidine Tablets USP, 150 mg and 300 mg
Approved
Approval ID
5a1cf9b3-6ad2-0805-e053-2991aa0ab837
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 26, 2017
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ranitidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-648
Application NumberANDA078542
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ranitidine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 26, 2017
FDA Product Classification
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
RANITIDINE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: BK76465IHM
Classification: ACTIM
Ranitidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-649
Application NumberANDA078542
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ranitidine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 26, 2017
FDA Product Classification
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
RANITIDINE HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: BK76465IHM
Classification: ACTIM