Cimetidine
CIMETIDINE TABLETS USP
Approved
Approval ID
a49ba8e3-e379-44f1-8ad2-b6dae53bbdf8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 26, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cimetidine
PRODUCT DETAILS
NDC Product Code54868-3315
Application NumberANDA074424
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 4, 2011
Generic NameCimetidine
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CIMETIDINEActive
Quantity: 400 mg in 1 1
Code: 80061L1WGD
Classification: ACTIB
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Cimetidine
PRODUCT DETAILS
NDC Product Code54868-3314
Application NumberANDA074424
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 4, 2011
Generic NameCimetidine
INGREDIENTS (9)
CIMETIDINEActive
Quantity: 300 mg in 1 1
Code: 80061L1WGD
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Cimetidine
PRODUCT DETAILS
NDC Product Code54868-3316
Application NumberANDA074424
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 4, 2011
Generic NameCimetidine
INGREDIENTS (9)
CIMETIDINEActive
Quantity: 800 mg in 1 1
Code: 80061L1WGD
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT