esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler pd-rx pharmaceuticals, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium 40 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-391
Product ID 72789-391_412329bd-ce50-d48d-e063-6294a90a9399
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 72789391
Hyphenated Format 72789-391

Supplemental Identifiers

RxCUI
606730
UPC
0372789391908
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
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-391-90)
source: ndc

Packages (1)

72789-391-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-391-90)

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": "412329bd-ce50-d48d-e063-6294a90a9399", "openfda": {"upc": ["0372789391908"], "unii": ["R6DXU4WAY9"], "rxcui": ["606730"], "spl_set_id": ["fdea1f5f-b717-4d49-8d70-0b373c959bf0"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-391-90)", "package_ndc": "72789-391-90", "marketing_start_date": "20240409"}], "brand_name": "Esomeprazole Magnesium", "product_id": "72789-391_412329bd-ce50-d48d-e063-6294a90a9399", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "72789-391", "generic_name": "Esomeprazole Magnesium", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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": "20151210", "listing_expiration_date": "20261231"}