esomeprazole sodium

Generic: esomeprazole sodium

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole sodium
Generic Name esomeprazole sodium
Labeler eugia us llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

esomeprazole sodium 40 mg/1

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-185
Product ID 55150-185_0f4cf0d6-61e7-429c-8658-e885e3c09b4a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204657
Listing Expiration 2026-12-31
Marketing Start 2016-08-10

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 55150185
Hyphenated Format 55150-185

Supplemental Identifiers

RxCUI
486501
UNII
L2C9GWQ43H

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 sodium (source: ndc)
Generic Name esomeprazole sodium (source: ndc)
Application Number ANDA204657 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (55150-185-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

55150-185-05 10 VIAL in 1 CARTON (55150-185-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Ingredients (1)

esomeprazole sodium (40 mg/1)

Linked Drug Pages (1)

Esomeprazole Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0f4cf0d6-61e7-429c-8658-e885e3c09b4a", "openfda": {"unii": ["L2C9GWQ43H"], "rxcui": ["486501"], "spl_set_id": ["45a15ba2-2aae-4edc-beaa-4a2357d87f32"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (55150-185-05)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "55150-185-05", "marketing_start_date": "20160810"}], "brand_name": "Esomeprazole Sodium", "product_id": "55150-185_0f4cf0d6-61e7-429c-8658-e885e3c09b4a", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "55150-185", "generic_name": "Esomeprazole Sodium", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole Sodium", "active_ingredients": [{"name": "ESOMEPRAZOLE SODIUM", "strength": "40 mg/1"}], "application_number": "ANDA204657", "marketing_category": "ANDA", "marketing_start_date": "20160810", "listing_expiration_date": "20261231"}