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Esomeprazole magnesium - Medication Information

Product NDC Code 70771-1494
Drug Name

Esomeprazole magnesium

Type Generic
Pharm Class Cytochrome P450 2C19 Inhibitors [MoA],
Proton Pump Inhibitor [EPC],
Proton Pump Inhibitors [MoA]
Active Ingredients
Esomeprazole magnesium dihydrate 40 mg/1
Route ORAL
Dosage Form CAPSULE, DELAYED RELEASE
RxCUI drug identifier 606726,
606730
Application Number ANDA206296
Labeler Name Zydus Lifesciences Limited
Packages
Package NDC Code Description
70771-1494-0 1000 capsule, delayed release in 1 bottle (70771-1494-0)
70771-1494-3 30 capsule, delayed release in 1 bottle (70771-1494-3)
70771-1494-9 90 capsule, delayed release in 1 bottle (70771-1494-9)
Check if available Online

Spl product data elements

Usually a list of ingredients in a drug product.
esomeprazole magnesium esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM DIHYDRATE ESOMEPRAZOLE ALCOHOL AMMONIA BUTYL ALCOHOL FD&C BLUE NO. 1 FD&C RED NO. 3 FERROSOFERRIC OXIDE GELATIN GLYCERYL MONO- AND DICAPRYLOCAPRATE HYDROXYPROPYL CELLULOSE (90000 WAMW) ISOPROPYL ALCOHOL MAGNESIUM OXIDE MAGNESIUM STEARATE MANNITOL METHACRYLIC ACID POLYSORBATE 80 POTASSIUM HYDROXIDE POVIDONE K30 PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER DARK BLUE OPAQUE (CAP) WHITE OPAQUE (BODY) CAPSULE 441;20mg esomeprazole magnesium esomeprazole magnesium ESOMEPRAZOLE MAGNESIUM DIHYDRATE ESOMEPRAZOLE ALCOHOL AMMONIA BUTYL ALCOHOL D&C RED NO. 28 FD&C BLUE NO. 1 FERROSOFERRIC OXIDE GELATIN GLYCERYL MONO- AND DICAPRYLOCAPRATE HYDROXYPROPYL CELLULOSE (90000 WAMW) ISOPROPYL ALCOHOL MAGNESIUM OXIDE MAGNESIUM STEARATE MANNITOL METHACRYLIC ACID POLYSORBATE 80 POTASSIUM HYDROXIDE POVIDONE K30 PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER BLUE OPAQUE (CAP) OPAQUE WHITE (BODY) CAPSULE 442;40mg

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1493-3 Esomeprazole Magnesium Delayed-release Capsules, USP 20 mg 30 Capsules NDC 70771-1494-3 Esomeprazole Magnesium Delayed-release Capsules, USP 40 mg 30 Capsules 20 mg 30s label 40 mg 30s label

Spl medguide

Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.
SPL MEDGUIDE

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API