Demeclocycline Hydrochloride
To reduce the development of drug-resistant bacteria and maintain the effectiveness of demeclocycline hydrochloride tablets and other antibacterial drugs, demeclocycline hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Approved
Approval ID
539add06-e0a0-401a-b4f6-20776084aa9c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2023
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
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 Code53746-555
Application NumberANDA065425
Product Classification
M
Marketing Category
C73584
G
Generic Name
Demeclocycline
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2023
FDA Product Classification
INGREDIENTS (13)
DEMECLOCYCLINE HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: 29O079NTYT
Classification: ACTIB
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53746-554
Application NumberANDA065425
Product Classification
M
Marketing Category
C73584
G
Generic Name
Demeclocycline
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2023
FDA Product Classification
INGREDIENTS (14)
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
DEMECLOCYCLINE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 29O079NTYT
Classification: ACTIB
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT