esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler advanced rx of tennessee, llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium 20 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0419
Product ID 80425-0419_1d8bcbd7-393e-9c1d-e063-6394a90a823c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211977
Listing Expiration 2026-12-31
Marketing Start 2024-07-18

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 804250419
Hyphenated Format 80425-0419

Supplemental Identifiers

RxCUI
606726
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
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0419-1)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0419-2)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0419-3)
source: ndc

Packages (3)

80425-0419-1 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0419-1) 80425-0419-2 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0419-2) 80425-0419-3 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0419-3)

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": "1d8bcbd7-393e-9c1d-e063-6394a90a823c", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["1d8bd104-66d4-8c19-e063-6394a90a3cb6"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0419-1)", "package_ndc": "80425-0419-1", "marketing_start_date": "20240718"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0419-2)", "package_ndc": "80425-0419-2", "marketing_start_date": "20240718"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0419-3)", "package_ndc": "80425-0419-3", "marketing_start_date": "20240718"}], "brand_name": "Esomeprazole Magnesium", "product_id": "80425-0419_1d8bcbd7-393e-9c1d-e063-6394a90a823c", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "80425-0419", "generic_name": "Esomeprazole Magnesium", "labeler_name": "Advanced Rx of Tennessee, LLC", "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": "20240718", "listing_expiration_date": "20261231"}