esomeprazole magnesium

Generic: esomeprazole magnesium capsule, delayed release

Labeler: allegiant health
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium capsule, delayed release
Labeler allegiant health
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

esomeprazole magnesium 20 mg/1

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-472
Product ID 69168-472_8544b126-0544-4f7c-a5f6-3cc1b136505d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212507
Listing Expiration 2026-12-31
Marketing Start 2025-05-15

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 69168472
Hyphenated Format 69168-472

Supplemental Identifiers

RxCUI
606726
UPC
0369168464421
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 capsule, delayed release (source: ndc)
Application Number ANDA212507 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69168-472-14) / 14 CAPSULE in 1 BOTTLE
  • 14 CAPSULE in 1 BOTTLE (69168-472-15)
  • 3 BOTTLE in 1 CARTON (69168-472-42) / 14 CAPSULE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69168-472-61) / 14 CAPSULE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (69168-472-62) / 14 CAPSULE in 1 BOTTLE
source: ndc

Packages (5)

Ingredients (1)

esomeprazole magnesium (20 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "8544b126-0544-4f7c-a5f6-3cc1b136505d", "openfda": {"upc": ["0369168464421"], "unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["42fa9084-89db-45ad-8212-4eeb53659a98"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69168-472-14)  / 14 CAPSULE in 1 BOTTLE", "package_ndc": "69168-472-14", "marketing_start_date": "20250515"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (69168-472-15)", "package_ndc": "69168-472-15", "marketing_start_date": "20250515"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (69168-472-42)  / 14 CAPSULE in 1 BOTTLE", "package_ndc": "69168-472-42", "marketing_start_date": "20250515"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69168-472-61)  / 14 CAPSULE in 1 BOTTLE", "package_ndc": "69168-472-61", "marketing_start_date": "20250515"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (69168-472-62)  / 14 CAPSULE in 1 BOTTLE", "package_ndc": "69168-472-62", "marketing_start_date": "20250515"}], "brand_name": "Esomeprazole Magnesium", "product_id": "69168-472_8544b126-0544-4f7c-a5f6-3cc1b136505d", "dosage_form": "CAPSULE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "69168-472", "generic_name": "esomeprazole magnesium capsule, delayed release", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA212507", "marketing_category": "ANDA", "marketing_start_date": "20250515", "listing_expiration_date": "20261231"}