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 dihydrate 20 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-352
Product ID 72789-352_38063934-d3b6-c6af-e063-6294a90a853c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205606
Listing Expiration 2026-12-31
Marketing Start 2016-04-21

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 72789352
Hyphenated Format 72789-352

Supplemental Identifiers

RxCUI
606726
UPC
0372789352305
UNII
36H71644EQ

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 ANDA205606 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-352-30)
source: ndc

Packages (1)

72789-352-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-352-30)

Ingredients (1)

esomeprazole magnesium dihydrate (20 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": "38063934-d3b6-c6af-e063-6294a90a853c", "openfda": {"upc": ["0372789352305"], "unii": ["36H71644EQ"], "rxcui": ["606726"], "spl_set_id": ["ac12cd05-10cf-4694-a9e8-e5f04fe162a7"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-352-30)", "package_ndc": "72789-352-30", "marketing_start_date": "20231009"}], "brand_name": "Esomeprazole Magnesium", "product_id": "72789-352_38063934-d3b6-c6af-e063-6294a90a853c", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "72789-352", "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 DIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA205606", "marketing_category": "ANDA", "marketing_start_date": "20160421", "listing_expiration_date": "20261231"}