esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: amerisource bergen
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler amerisource bergen
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium trihydrate 20 mg/1

Manufacturer
Amerisource Bergen

Identifiers & Regulatory

Product NDC 46122-821
Product ID 46122-821_3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db46
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209339
Listing Expiration 2026-12-31
Marketing Start 2025-08-30

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 46122821
Hyphenated Format 46122-821

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
  • 3 BOTTLE in 1 CARTON (46122-821-59) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (46122-821-61) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (46122-821-62) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (3)

46122-821-59 3 BOTTLE in 1 CARTON (46122-821-59) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 46122-821-61 1 BOTTLE in 1 CARTON (46122-821-61) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 46122-821-62 2 BOTTLE in 1 CARTON (46122-821-62) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

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": "3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db46", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db46"], "manufacturer_name": ["Amerisource Bergen"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (46122-821-59)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "46122-821-59", "marketing_start_date": "20250830"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (46122-821-61)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "46122-821-61", "marketing_start_date": "20250830"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (46122-821-62)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "46122-821-62", "marketing_start_date": "20250830"}], "brand_name": "Esomeprazole Magnesium", "product_id": "46122-821_3c6c2fd5-1a0f-44f7-8d02-c9bc26b8db46", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "46122-821", "generic_name": "Esomeprazole Magnesium", "labeler_name": "Amerisource Bergen", "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": "20250830", "listing_expiration_date": "20261231"}