esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

esomeprazole magnesium trihydrate 40 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6581
Product ID 0904-6581_5488571a-b29b-4a7b-9589-0947411e2cfe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078279
Listing Expiration 2026-12-31
Marketing Start 2015-12-10

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 09046581
Hyphenated Format 0904-6581

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
  • 60 BLISTER PACK in 1 CARTON (0904-6581-68) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6581-68 60 BLISTER PACK in 1 CARTON (0904-6581-68) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

Ingredients (1)

esomeprazole magnesium trihydrate (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": "5488571a-b29b-4a7b-9589-0947411e2cfe", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606730"], "spl_set_id": ["ba65c73d-fc7d-491e-aaaa-cf45a7783395"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "60 BLISTER PACK in 1 CARTON (0904-6581-68)  / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-6581-68", "marketing_start_date": "20151210"}], "brand_name": "Esomeprazole Magnesium", "product_id": "0904-6581_5488571a-b29b-4a7b-9589-0947411e2cfe", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0904-6581", "generic_name": "Esomeprazole Magnesium", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE", "strength": "40 mg/1"}], "application_number": "ANDA078279", "marketing_category": "ANDA", "marketing_start_date": "20151210", "listing_expiration_date": "20261231"}