leader esomeprazole magnesium

Generic: esomeprazole

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

Drug Facts

Product Profile

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

esomeprazole 20 mg/1

Manufacturer
Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0727
Product ID 70000-0727_70bfe4f8-4dba-4b46-abbd-7ff48928c9d5
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207193
Listing Expiration 2026-12-31
Marketing Start 2025-04-02

Pharmacologic Class

Established (EPC)
proton pump inhibitor [epc]
Mechanism of Action
proton pump inhibitors [moa] cytochrome p450 2c19 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000727
Hyphenated Format 70000-0727

Supplemental Identifiers

RxCUI
606726
UNII
N3PA6559FT
NUI
N0000175525 N0000000147 N0000182140

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 leader esomeprazole magnesium (source: ndc)
Generic Name esomeprazole (source: ndc)
Application Number ANDA207193 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3 BOTTLE in 1 CARTON (70000-0727-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (70000-0727-2) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

70000-0727-1 3 BOTTLE in 1 CARTON (70000-0727-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 70000-0727-2 1 BOTTLE in 1 CARTON (70000-0727-2) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

esomeprazole (20 mg/1)

Linked Drug Pages (1)

leader esomeprazole magnesium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "70bfe4f8-4dba-4b46-abbd-7ff48928c9d5", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["N3PA6559FT"], "rxcui": ["606726"], "spl_set_id": ["c9472b82-d345-4531-bf07-bd55c94876ab"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (70000-0727-1)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "70000-0727-1", "marketing_start_date": "20250423"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0727-2)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "70000-0727-2", "marketing_start_date": "20250402"}], "brand_name": "leader esomeprazole magnesium", "product_id": "70000-0727_70bfe4f8-4dba-4b46-abbd-7ff48928c9d5", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "70000-0727", "generic_name": "Esomeprazole", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "leader esomeprazole magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA207193", "marketing_category": "ANDA", "marketing_start_date": "20250402", "listing_expiration_date": "20261231"}