ESOMEPRAZOLE MAGNESIUM

Registrants (1)

DirectRX

DUNS Number

079254320

Manufacturing Establishments (1)

DirectRX

Labeler

DirectRX

Registrant

DirectRX

DUNS Number

079254320

Products (1)

ESOMEPRAZOLE MAGNESIUM DR

NDC Product Code

61919-789

Application Number

ANDA208333

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 14, 2019

Ingredients

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

Code: NX76LV5T8JClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

BEETInactive

Code: N487KM8COKClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

MEGLUMINEInactive

Code: 6HG8UB2MUYClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLOXAMER 188Inactive

Code: LQA7B6G8JGClass: IACT

METHYL ALCOHOLInactive

Code: Y4S76JWI15Class: IACT

METHYLENE CHLORIDEInactive

Code: 588X2YUY0AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

EsomeprazoleActive

Code: R6DXU4WAY9Class: ACTIMQuantity: 20 mg in 1 1

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Registrants (1)

Manufacturing Establishments (1)

Products (1)

ESOMEPRAZOLE MAGNESIUM DR