esomeprazole magnesium
Generic: esomeprazole magnesium capsule, delayed release
Labeler: allegiant healthDrug Facts
Product Profile
Brand Name
esomeprazole magnesium
Generic Name
esomeprazole magnesium capsule, delayed release
Labeler
allegiant health
Dosage Form
CAPSULE
Routes
Active Ingredients
esomeprazole magnesium 20 mg/1
Manufacturer
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
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
69168472
Hyphenated Format
69168-472
Supplemental Identifiers
RxCUI
UPC
UNII
Packaging Origin
Original Packager
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
source: ndc
Resolved Composition
Strengths
- 20 mg/1
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
Packages (5)
69168-472-14
1 BOTTLE in 1 CARTON (69168-472-14) / 14 CAPSULE in 1 BOTTLE
69168-472-15
14 CAPSULE in 1 BOTTLE (69168-472-15)
69168-472-42
3 BOTTLE in 1 CARTON (69168-472-42) / 14 CAPSULE in 1 BOTTLE
69168-472-61
1 BOTTLE in 1 CARTON (69168-472-61) / 14 CAPSULE in 1 BOTTLE
69168-472-62
3 BOTTLE in 1 CARTON (69168-472-62) / 14 CAPSULE in 1 BOTTLE
Ingredients (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"}