esomeprazole magnesium

Generic: esomeprazole magnesium

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

Drug Facts

Product Profile

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

esomeprazole magnesium 20 mg/1

Manufacturer
Medsource Pharmaceuticals

Identifiers & Regulatory

Product NDC 45865-163
Product ID 45865-163_1278c4e8-89c4-94b5-e063-6294a90a7d73
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 45865163
Hyphenated Format 45865-163

Supplemental Identifiers

RxCUI
606726
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
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-163-30)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-163-60)
source: ndc

Packages (2)

45865-163-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-163-30) 45865-163-60 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-163-60)

Ingredients (1)

esomeprazole magnesium (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": "1278c4e8-89c4-94b5-e063-6294a90a7d73", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["1278cf6f-cc7a-462b-e063-6394a90a34e5"], "manufacturer_name": ["Medsource Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-163-30)", "package_ndc": "45865-163-30", "marketing_start_date": "20220728"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-163-60)", "package_ndc": "45865-163-60", "marketing_start_date": "20201228"}], "brand_name": "Esomeprazole Magnesium", "product_id": "45865-163_1278c4e8-89c4-94b5-e063-6294a90a7d73", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "45865-163", "generic_name": "Esomeprazole Magnesium", "labeler_name": "Medsource Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA078279", "marketing_category": "ANDA", "marketing_start_date": "20151210", "listing_expiration_date": "20261231"}