esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler a-s medication solutions
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium 40 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5134
Product ID 50090-5134_006cdc3e-9071-44fa-8394-707f05018c9b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078279
Listing Expiration 2026-12-31
Marketing Start 2019-09-17

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 500905134
Hyphenated Format 50090-5134

Supplemental Identifiers

RxCUI
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 ANDA078279 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5134-0)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5134-1)
source: ndc

Packages (2)

50090-5134-0 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5134-0) 50090-5134-1 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5134-1)

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": "006cdc3e-9071-44fa-8394-707f05018c9b", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606730"], "spl_set_id": ["71956762-d2f7-4763-9afe-1ca8f32a3cbb"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5134-0)", "package_ndc": "50090-5134-0", "marketing_start_date": "20231215"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5134-1)", "package_ndc": "50090-5134-1", "marketing_start_date": "20200818"}], "brand_name": "Esomeprazole Magnesium", "product_id": "50090-5134_006cdc3e-9071-44fa-8394-707f05018c9b", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "50090-5134", "generic_name": "Esomeprazole Magnesium", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "40 mg/1"}], "application_number": "ANDA078279", "marketing_category": "ANDA", "marketing_start_date": "20190917", "listing_expiration_date": "20261231"}