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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68151-1497
Application NumberANDA074246
Product Classification
M
Marketing Category
C73584
G
Generic Name
cimetidine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2013
FDA Product Classification
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