MedPath
FDA Product

Esomeprazole Magnesium

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

Basic Information

Esomeprazole Magnesium

0904-6581

Regulatory Information

0904-6581

ANDA078279

C73584

December 13, 2022

USA

These highlights do not include all the information needed to use ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole)

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

191427277

Active Ingredients

Propylene Glycol

Code: 6DC9Q167V3

Class Code: IACT

Potassium Hydroxide

Code: WZH3C48M4T

Class Code: IACT

Shellac

Code: 46N107B71O

Class Code: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

Magnesium Stearate

Code: 70097M6I30

Class Code: IACT

Methacrylic Acid

Code: 1CS02G8656

Class Code: IACT

Polysorbate 80

Code: 6OZP39ZG8H

Class Code: IACT

Triethyl Citrate

Code: 8Z96QXD6UM

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

Fd&C Blue No. 1

Code: H3R47K3TBD

Class Code: IACT

Titanium Dioxide

Code: 15FIX9V2JP

Class Code: IACT

Ammonia

Code: 5138Q19F1X

Class Code: IACT

Esomeprazole Magnesium

Quantity: 40 mg in 1 1

Code: R6DXU4WAY9

Class Code: ACTIM

Ferrosoferric Oxide

Code: XM0M87F357

Class Code: IACT

Butyl Alcohol

Code: 8PJ61P6TS3

Class Code: IACT

Alcohol

Code: 3K9958V90M

Class Code: IACT

Isopropyl Alcohol

Code: ND2M416302

Class Code: IACT

Glyceryl Monostearate

Code: 230OU9XXE4

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

Talc

Code: 7SEV7J4R1U

Class Code: IACT

Active Moieties

Esomeprazole

Code: N3PA6559FT

© Copyright 2025. All Rights Reserved by MedPath