MYCOPHENOLIC ACID

Manufacturing Establishments1

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

Alkem Laboratories Limited

Labeler

Ascend Laboratories, LLC

DUNS Number

677605851

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

67877-427

Application Number

ANDA208315

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 20, 2022

Ingredients

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

Mycophenolic acidActive

Code: WX877SQI1GClass: ACTIMQuantity: 360 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive

Code: 87Y6436BKRClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990Class: IACT