Demeclocycline Hydrochloride

Manufacturing Establishments1

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

American Health Packaging

Labeler

American Health Packaging

DUNS Number

929561009

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

60687-691

Application Number

ANDA065425

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 28, 2023

Ingredients

ALGINIC ACIDInactive

Code: 8C3Z4148WZClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

ETHYLCELLULOSE, UNSPECIFIEDInactive

Code: 7Z8S9VYZ4BClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

DemeclocyclineActive

Code: 29O079NTYTClass: ACTIBQuantity: 150 mg in 1 1

D&C RED NO. 27Inactive

Code: 2LRS185U6KClass: IACT