esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: cvs pharmacy
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler cvs pharmacy
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium 20 mg/1

Manufacturer
CVS Pharmacy

Identifiers & Regulatory

Product NDC 51316-563
Product ID 51316-563_39a6ed03-0253-3a4a-7736-47cc86bf6ba0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211571
Listing Expiration 2026-12-31
Marketing Start 2025-08-30

Pharmacologic Class

Classes
cytochrome p450 2c19 inhibitors [moa] proton pump inhibitor [epc] proton pump inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51316563
Hyphenated Format 51316-563

Supplemental Identifiers

RxCUI
433733
UNII
R6DXU4WAY9

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name esomeprazole magnesium (source: ndc)
Generic Name esomeprazole magnesium (source: ndc)
Application Number ANDA211571 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51316-563-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (51316-563-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

51316-563-14 1 BOTTLE in 1 CARTON (51316-563-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 51316-563-42 3 BOTTLE in 1 CARTON (51316-563-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

esomeprazole magnesium (20 mg/1)

Linked Drug Pages (1)

Esomeprazole Magnesium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "39a6ed03-0253-3a4a-7736-47cc86bf6ba0", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["433733"], "spl_set_id": ["0b3b2f9b-f7f3-1a32-4e14-f10aecd6aabb"], "manufacturer_name": ["CVS Pharmacy"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51316-563-14)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "51316-563-14", "marketing_start_date": "20250830"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (51316-563-42)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "51316-563-42", "marketing_start_date": "20250830"}], "brand_name": "Esomeprazole Magnesium", "product_id": "51316-563_39a6ed03-0253-3a4a-7736-47cc86bf6ba0", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "51316-563", "generic_name": "Esomeprazole Magnesium", "labeler_name": "CVS Pharmacy", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA211571", "marketing_category": "ANDA", "marketing_start_date": "20250830", "listing_expiration_date": "20261231"}