Demeclocycline Hydrochloride

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Amneal Pharmaceuticals Private Limited

Labeler

Amneal Pharmaceuticals of New York LLC

DUNS Number

650762060

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

53746-555

Application Number

ANDA065425

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 16, 2023

Ingredients

DemeclocyclineActive

Code: 29O079NTYTClass: ACTIBQuantity: 300 mg in 1 1

ALGINIC ACIDInactive

Code: 8C3Z4148WZClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT