Cimetidine
CIMETIDINE TABLETS USP819282048305Rx only
Approved
Approval ID
615823a3-07ec-4469-83d9-ac4078c2c22e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 17, 2013
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
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 Code33261-024
Application NumberANDA074151
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cimetidine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2013
FDA Product Classification
INGREDIENTS (18)
CIMETIDINEActive
Quantity: 400 mg in 1 1
Code: 80061L1WGD
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT