esomeprazole

Generic: esomeprazole magnesium

Labeler: cvs
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

esomeprazole magnesium 20 mg/1

Manufacturer
CVS

Identifiers & Regulatory

Product NDC 51316-715
Product ID 51316-715_3ed41fde-979d-6204-e063-6394a90ad1c1
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212866
Listing Expiration 2026-12-31
Marketing Start 2022-09-02

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 51316715
Hyphenated Format 51316-715

Supplemental Identifiers

RxCUI
606726
UPC
0050428274255
UNII
R6DXU4WAY9

Packaging Origin

Original Packager
true

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 (source: ndc)
Generic Name esomeprazole magnesium (source: ndc)
Application Number ANDA212866 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (51316-715-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (51316-715-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (51316-715-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (3)

51316-715-14 1 BOTTLE in 1 CARTON (51316-715-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 51316-715-28 2 BOTTLE in 1 CARTON (51316-715-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 51316-715-42 3 BOTTLE in 1 CARTON (51316-715-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

esomeprazole magnesium (20 mg/1)

Linked Drug Pages (1)

Esomeprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3ed41fde-979d-6204-e063-6394a90ad1c1", "openfda": {"upc": ["0050428274255"], "unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["b68035d0-195a-41e8-9928-8b1bd57917c0"], "manufacturer_name": ["CVS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51316-715-14)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "51316-715-14", "marketing_start_date": "20220902"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (51316-715-28)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "51316-715-28", "marketing_start_date": "20220902"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (51316-715-42)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "51316-715-42", "marketing_start_date": "20220902"}], "brand_name": "Esomeprazole", "product_id": "51316-715_3ed41fde-979d-6204-e063-6394a90ad1c1", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "51316-715", "generic_name": "ESOMEPRAZOLE MAGNESIUM", "labeler_name": "CVS", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Esomeprazole", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA212866", "marketing_category": "ANDA", "marketing_start_date": "20220902", "listing_expiration_date": "20261231"}