MedPath
FDA Product

NEXIUM

Product approved by U.S. Food and Drug Administration (US)

Basic Information

NEXIUM

61919-509

Regulatory Information

61919-509

NDA021153

C73594

March 28, 2019

USA

NEXIUM

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

DIRECT RX

079254320

Active Ingredients

GLYCERYL MONOSTEARATE

Code: 230OU9XXE4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

POTASSIUM SORBATE

Code: 1VPU26JZZ4

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

METHACRYLIC ACID

Code: 1CS02G8656

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

ANHYDROUS DEXTROSE

Code: 5SL0G7R0OK

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

ESOMEPRAZOLE MAGNESIUM

Quantity: 40 mg in 1 1

Code: R6DXU4WAY9

Class Code: ACTIM

Active Moieties

ESOMEPRAZOLE

Code: N3PA6559FT

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