Cimetidine
Approved
Approval ID
a147850e-f881-4f9b-bf37-1b9e8cdf4020
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 21, 2013
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cimetidine
PRODUCT DETAILS
NDC Product Code68151-1497
Application NumberANDA074246
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 21, 2013
Generic Namecimetidine
INGREDIENTS (19)
CIMETIDINEActive
Quantity: 200 mg in 1 1
Code: 80061L1WGD
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
VANILLINInactive
Code: CHI530446X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT