CIMETIDINE
Cimetidine Tablets, USP
Approved
Approval ID
01997826-7ca1-473e-bfc9-075b14b58a35
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
Products 4
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 Code62135-630
Application NumberANDA074329
Product Classification
M
Marketing Category
C73584
G
Generic Name
CIMETIDINE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2023
FDA Product Classification
INGREDIENTS (13)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CIMETIDINEActive
Quantity: 200 mg in 1 1
Code: 80061L1WGD
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CIMETIDINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-631
Application NumberANDA074329
Product Classification
M
Marketing Category
C73584
G
Generic Name
CIMETIDINE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2023
FDA Product Classification
INGREDIENTS (13)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CIMETIDINEActive
Quantity: 300 mg in 1 1
Code: 80061L1WGD
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CIMETIDINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-632
Application NumberANDA074329
Product Classification
M
Marketing Category
C73584
G
Generic Name
CIMETIDINE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2023
FDA Product Classification
INGREDIENTS (13)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CIMETIDINEActive
Quantity: 400 mg in 1 1
Code: 80061L1WGD
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CIMETIDINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-633
Application NumberANDA074329
Product Classification
M
Marketing Category
C73584
G
Generic Name
CIMETIDINE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2023
FDA Product Classification
INGREDIENTS (12)
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
CIMETIDINEActive
Quantity: 800 mg in 1 1
Code: 80061L1WGD
Classification: ACTIB