Mycophenolic Acid

Manufacturing Establishments1

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

Intas Pharmaceuticals Ltd

Labeler

Accord Healthcare Inc.

DUNS Number

725927649

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

16729-189

Application Number

ANDA202555

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 17, 2024

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8JClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Mycophenolic acidActive

Code: WX877SQI1GClass: ACTIMQuantity: 360 mg in 1 1

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT