RANITIDINE
PRODUCT INFORMATION Rx Only
Approved
Approval ID
7de06786-bf44-4928-aa69-47ab71f27633
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 17, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4048
Application NumberANDA075208
Product Classification
M
Marketing Category
C73584
G
Generic Name
RANITIDINE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2011
FDA Product Classification
INGREDIENTS (9)
RANITIDINE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: BK76465IHM
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
RANITIDINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4350
Application NumberANDA075208
Product Classification
M
Marketing Category
C73584
G
Generic Name
RANITIDINE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2011
FDA Product Classification
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
RANITIDINE HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: BK76465IHM
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT