MedPath
FDA Product

ESOMEPRAZOLE MAGNESIUM

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

Basic Information

ESOMEPRAZOLE MAGNESIUM

72189-318

Regulatory Information

72189-318

ANDA211977

C73584

March 3, 2023

USA

Esomeprazole

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

Direct Rx

079254320

Active Ingredients

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

ESOMEPRAZOLE MAGNESIUM

Quantity: 40 mg in 1 1

Code: R6DXU4WAY9

Class Code: ACTIM

TALC

Code: 7SEV7J4R1U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

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

Code: NX76LV5T8J

Class Code: IACT

GLYCERYL MONOSTEARATE

Code: 230OU9XXE4

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

DIMETHICONE

Code: 92RU3N3Y1O

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

Active Moieties

ESOMEPRAZOLE

Code: N3PA6559FT

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