esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler aurobindo pharma limited
Dosage Form GRANULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium trihydrate 5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-802
Product ID 59651-802_e691b51e-2e31-4408-81c4-5afec6f9bbb6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218948
Listing Expiration 2026-12-31
Marketing Start 2025-04-15

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 59651802
Hyphenated Format 59651-802

Supplemental Identifiers

RxCUI
692576 692578 1297761
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 ANDA218948 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 GRANULE, DELAYED RELEASE in 1 CARTON (59651-802-30)
source: ndc

Packages (1)

59651-802-30 30 GRANULE, DELAYED RELEASE in 1 CARTON (59651-802-30)

Ingredients (1)

esomeprazole magnesium trihydrate (5 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": "e691b51e-2e31-4408-81c4-5afec6f9bbb6", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["692576", "692578", "1297761"], "spl_set_id": ["e691b51e-2e31-4408-81c4-5afec6f9bbb6"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 GRANULE, DELAYED RELEASE in 1 CARTON (59651-802-30)", "package_ndc": "59651-802-30", "marketing_start_date": "20250415"}], "brand_name": "Esomeprazole Magnesium", "product_id": "59651-802_e691b51e-2e31-4408-81c4-5afec6f9bbb6", "dosage_form": "GRANULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "59651-802", "generic_name": "Esomeprazole Magnesium", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE", "strength": "5 mg/1"}], "application_number": "ANDA218948", "marketing_category": "ANDA", "marketing_start_date": "20250415", "listing_expiration_date": "20261231"}