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 20 mg/1

Manufacturer
LEADER/ Cardinal Health 110, Inc.

Identifiers & Regulatory

Product NDC 70000-0714
Product ID 70000-0714_1bbc5874-ab67-0f48-be18-65a1e402dc31
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207198
Listing Expiration 2026-12-31
Marketing Start 2025-03-01

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 700000714
Hyphenated Format 70000-0714

Supplemental Identifiers

RxCUI
606726
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 ANDA207198 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70000-0714-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (70000-0714-2) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (70000-0714-3) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (3)

70000-0714-1 1 BOTTLE in 1 CARTON (70000-0714-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 70000-0714-2 2 BOTTLE in 1 CARTON (70000-0714-2) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 70000-0714-3 3 BOTTLE in 1 CARTON (70000-0714-3) / 14 CAPSULE, 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": "1bbc5874-ab67-0f48-be18-65a1e402dc31", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["254ab988-a95d-c97e-c978-5b3ba56dce5f"], "manufacturer_name": ["LEADER/ Cardinal Health 110, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70000-0714-1)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "70000-0714-1", "marketing_start_date": "20250301"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (70000-0714-2)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "70000-0714-2", "marketing_start_date": "20250301"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (70000-0714-3)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "70000-0714-3", "marketing_start_date": "20250301"}], "brand_name": "Esomeprazole Magnesium", "product_id": "70000-0714_1bbc5874-ab67-0f48-be18-65a1e402dc31", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "70000-0714", "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", "strength": "20 mg/1"}], "application_number": "ANDA207198", "marketing_category": "ANDA", "marketing_start_date": "20250301", "listing_expiration_date": "20261231"}