Demeclocycline Hydrochloride

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Epic Pharma, LLC

DUNS Number

827915443

Manufacturing Establishments1

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

Epic Pharma, LLC

Labeler

Epic Pharma, LLC

Registrant

Epic Pharma, LLC

DUNS Number

827915443

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

42806-143

Application Number

ANDA065447

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 8, 2023

Ingredients

DemeclocyclineActive

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

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZClass: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

D&C RED NO. 30Inactive

Code: 2S42T2808BClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

HYPROMELLOSE 2910 (10000 MPA.S)Inactive

Code: 0HO1H52958Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

D&C RED NO. 27Inactive

Code: 2LRS185U6KClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

POLYDEXTROSEInactive

Code: VH2XOU12IEClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OHClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT