sevelamer hydrochloride

Manufacturing Establishments1

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

Glenmark Pharmaceuticals Limited

Labeler

Glenmark Pharmaceuticals Inc., USA

DUNS Number

862603186

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

68462-447

Application Number

ANDA204724

Marketing Category

ANDA (C73584)

Route of Administration

PARENTERAL

Effective Date

June 30, 2020

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SevelamerActive

Code: GLS2PGI8QGClass: ACTIBQuantity: 800 mg in 1 1

TALCInactive

Code: 7SEV7J4R1UClass: IACT

DIACETYLATED MONOGLYCERIDESInactive

Code: 5Z17386USFClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

HYPROMELLOSE 2910 (50 MPA.S)Inactive

Code: 1IVH67816NClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

ZINC STEARATEInactive

Code: H92E6QA4FVClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT