esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler somerset therapeutics, llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium 40 mg/1

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-815
Product ID 70069-815_26a0088b-92d3-4b6b-e063-6394a90a731e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213859
Listing Expiration 2026-12-31
Marketing Start 2023-08-15

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 70069815
Hyphenated Format 70069-815

Supplemental Identifiers

RxCUI
606726 606730
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 ANDA213859 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70069-815-10)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70069-815-30)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70069-815-90)
source: ndc

Packages (3)

70069-815-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70069-815-10) 70069-815-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70069-815-30) 70069-815-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70069-815-90)

Ingredients (1)

esomeprazole magnesium (40 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": "26a0088b-92d3-4b6b-e063-6394a90a731e", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606726", "606730"], "spl_set_id": ["02893318-e394-5a8e-e063-6394a90a885a"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70069-815-10)", "package_ndc": "70069-815-10", "marketing_start_date": "20230815"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70069-815-30)", "package_ndc": "70069-815-30", "marketing_start_date": "20230815"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70069-815-90)", "package_ndc": "70069-815-90", "marketing_start_date": "20230815"}], "brand_name": "Esomeprazole Magnesium", "product_id": "70069-815_26a0088b-92d3-4b6b-e063-6394a90a731e", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "70069-815", "generic_name": "Esomeprazole magnesium", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "40 mg/1"}], "application_number": "ANDA213859", "marketing_category": "ANDA", "marketing_start_date": "20230815", "listing_expiration_date": "20261231"}