CIMETIDINE
CIMETIDINE TABLETS, USP
Approved
Approval ID
9fde45b1-b40c-4374-81ad-f2bf1015950b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 28, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CIMETIDINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-048
Application NumberANDA074246
Product Classification
M
Marketing Category
C73584
G
Generic Name
CIMETIDINE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 28, 2011
FDA Product Classification
INGREDIENTS (15)
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
VANILLINInactive
Code: CHI530446X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CIMETIDINEActive
Quantity: 300 mg in 1 1
Code: 80061L1WGD
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT