Demeclocycline Hydrochloride
Demeclocycline Hydrochloride Tablets, USP Rx Only 8469101/0722F
Approved
Approval ID
e6adaf70-5ff9-4395-bff1-0f332090cb80
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Demeclocycline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-691
Application NumberANDA065425
Product Classification
M
Marketing Category
C73584
G
Generic Name
Demeclocycline
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (14)
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DEMECLOCYCLINE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 29O079NTYT
Classification: ACTIB
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
Demeclocycline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-705
Application NumberANDA065425
Product Classification
M
Marketing Category
C73584
G
Generic Name
Demeclocycline
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (13)
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
DEMECLOCYCLINE HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: 29O079NTYT
Classification: ACTIB