Chemet

Manufacturing Establishments1

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

Labeler

Recordati Rare Diseases, Inc.

DUNS Number

006422406

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

NDC Product Code

55292-201

Application Number

NDA019998

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

January 11, 2023

Ingredients

SUCROSEInactive

Code: C151H8M554Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

Code: DX1U2629QEClass: ACTIBQuantity: 100 mg in 1 1

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT