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 trihydrate 20 mg/1

Manufacturer
LEADER/ CARDINAL HEALTH 110, INC.

Identifiers & Regulatory

Product NDC 70000-0738
Product ID 70000-0738_08980e5c-b70f-43a1-97ec-1b3030a84628
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209339
Listing Expiration 2026-12-31
Marketing Start 2025-10-03

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 700000738
Hyphenated Format 70000-0738

Supplemental Identifiers

RxCUI
606726
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 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 (70000-0738-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70000-0738-2)
source: ndc

Packages (1)

70000-0738-1 2 BOTTLE in 1 CARTON (70000-0738-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70000-0738-2)

Ingredients (1)

esomeprazole magnesium trihydrate (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": "08980e5c-b70f-43a1-97ec-1b3030a84628", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["aef20ccb-1eb7-4c79-af8e-81220eb73752"], "manufacturer_name": ["LEADER/ CARDINAL HEALTH 110, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 CARTON (70000-0738-1)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70000-0738-2)", "package_ndc": "70000-0738-1", "marketing_start_date": "20251003"}], "brand_name": "Esomeprazole Magnesium", "product_id": "70000-0738_08980e5c-b70f-43a1-97ec-1b3030a84628", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "70000-0738", "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 TRIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA209339", "marketing_category": "ANDA", "marketing_start_date": "20251003", "listing_expiration_date": "20261231"}