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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3315
Application NumberANDA074424
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cimetidine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2011
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3314
Application NumberANDA074424
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cimetidine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2011
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3316
Application NumberANDA074424
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cimetidine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2011
FDA Product Classification
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