nexium

Generic: esomeprazole magnesium

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nexium
Generic Name esomeprazole magnesium
Labeler astrazeneca pharmaceuticals lp
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium trihydrate 40 mg/1

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0186-5040
Product ID 0186-5040_d8251328-3547-4a76-8ec8-1b2338dbbedf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021153
Listing Expiration 2026-12-31
Marketing Start 2001-03-19

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 01865040
Hyphenated Format 0186-5040

Supplemental Identifiers

RxCUI
606726 606728 606730 606731 692576 692578 861568 861570 861576 861583 1297658 1297660 1297761 1297763
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 nexium (source: ndc)
Generic Name esomeprazole magnesium (source: ndc)
Application Number NDA021153 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5040-31)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5040-54)
source: ndc

Packages (2)

0186-5040-31 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5040-31) 0186-5040-54 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5040-54)

Ingredients (1)

esomeprazole magnesium trihydrate (40 mg/1)

Linked Drug Pages (1)

NEXIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d8251328-3547-4a76-8ec8-1b2338dbbedf", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606726", "606728", "606730", "606731", "692576", "692578", "861568", "861570", "861576", "861583", "1297658", "1297660", "1297761", "1297763"], "spl_set_id": ["f4853677-1622-4037-688b-fdf533a11d96"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5040-31)", "package_ndc": "0186-5040-31", "marketing_start_date": "20010319"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5040-54)", "package_ndc": "0186-5040-54", "marketing_start_date": "20010319"}], "brand_name": "NEXIUM", "product_id": "0186-5040_d8251328-3547-4a76-8ec8-1b2338dbbedf", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0186-5040", "generic_name": "Esomeprazole magnesium", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NEXIUM", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE", "strength": "40 mg/1"}], "application_number": "NDA021153", "marketing_category": "NDA", "marketing_start_date": "20010319", "listing_expiration_date": "20261231"}