esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: leader/ cardinal health 110, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler leader/ cardinal health 110, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium dihydrate 20 mg/1

Manufacturer
LEADER/ CARDINAL HEALTH 110, INC.

Identifiers & Regulatory

Product NDC 70000-0731
Product ID 70000-0731_3fad3e71-9b6c-4b72-8637-2ac587b5861a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209339
Listing Expiration 2026-12-31
Marketing Start 2025-04-09

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 700000731
Hyphenated Format 70000-0731

Supplemental Identifiers

RxCUI
606726
UNII
36H71644EQ

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 magnesium (source: ndc)
Generic Name esomeprazole magnesium (source: ndc)
Application Number ANDA209339 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 2 BOTTLE in 1 CARTON (70000-0731-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70000-0731-2)
source: ndc

Packages (1)

70000-0731-1 2 BOTTLE in 1 CARTON (70000-0731-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70000-0731-2)

Ingredients (1)

esomeprazole magnesium dihydrate (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": "3fad3e71-9b6c-4b72-8637-2ac587b5861a", "openfda": {"unii": ["36H71644EQ"], "rxcui": ["606726"], "spl_set_id": ["c98b4332-ce47-422e-be54-f3eee0762354"], "manufacturer_name": ["LEADER/ CARDINAL HEALTH 110, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 CARTON (70000-0731-1)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70000-0731-2)", "package_ndc": "70000-0731-1", "marketing_start_date": "20250409"}], "brand_name": "ESOMEPRAZOLE MAGNESIUM", "product_id": "70000-0731_3fad3e71-9b6c-4b72-8637-2ac587b5861a", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "70000-0731", "generic_name": "ESOMEPRAZOLE MAGNESIUM", "labeler_name": "LEADER/ CARDINAL HEALTH 110, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ESOMEPRAZOLE MAGNESIUM", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA209339", "marketing_category": "ANDA", "marketing_start_date": "20250409", "listing_expiration_date": "20261231"}