esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler asclemed usa, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium 20 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-904
Product ID 76420-904_2cbe433d-9180-e5aa-e063-6394a90a452d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211977
Listing Expiration 2026-12-31
Marketing Start 2020-06-02

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 76420904
Hyphenated Format 76420-904

Supplemental Identifiers

RxCUI
606726 606730
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 ANDA211977 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-00)
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-01)
  • 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-12)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-30)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-60)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-90)
source: ndc

Packages (6)

76420-904-00 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-00) 76420-904-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-01) 76420-904-12 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-12) 76420-904-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-30) 76420-904-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-60) 76420-904-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-90)

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": "2cbe433d-9180-e5aa-e063-6394a90a452d", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606726", "606730"], "spl_set_id": ["2690dbe7-e559-4de8-9582-79b627af1964"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-00)", "package_ndc": "76420-904-00", "marketing_start_date": "20250128"}, {"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-01)", "package_ndc": "76420-904-01", "marketing_start_date": "20250128"}, {"sample": false, "description": "120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-12)", "package_ndc": "76420-904-12", "marketing_start_date": "20250128"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-30)", "package_ndc": "76420-904-30", "marketing_start_date": "20250128"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-60)", "package_ndc": "76420-904-60", "marketing_start_date": "20250128"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-904-90)", "package_ndc": "76420-904-90", "marketing_start_date": "20250128"}], "brand_name": "Esomeprazole Magnesium", "product_id": "76420-904_2cbe433d-9180-e5aa-e063-6394a90a452d", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "76420-904", "generic_name": "Esomeprazole Magnesium", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA211977", "marketing_category": "ANDA", "marketing_start_date": "20200602", "listing_expiration_date": "20261231"}