esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler aurobindo pharma limited
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium dihydrate 40 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-784
Product ID 65862-784_7da643d0-40fb-4ead-8d34-a95c2a8334f7
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 65862784
Hyphenated Format 65862-784

Supplemental Identifiers

RxCUI
606726 606730
UNII
36H71644EQ

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 esomeprazole magnesium (source: ndc)
Generic Name esomeprazole magnesium (source: ndc)
Application Number ANDA205606 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-01)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-30)
  • 10 BLISTER PACK in 1 CARTON (65862-784-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (65862-784-10)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-90)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-99)
source: ndc

Packages (5)

65862-784-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-01) 65862-784-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-30) 65862-784-78 10 BLISTER PACK in 1 CARTON (65862-784-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (65862-784-10) 65862-784-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-90) 65862-784-99 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-99)

Ingredients (1)

esomeprazole magnesium dihydrate (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": "7da643d0-40fb-4ead-8d34-a95c2a8334f7", "openfda": {"unii": ["36H71644EQ"], "rxcui": ["606726", "606730"], "spl_set_id": ["f4ae091d-9b74-4a0e-ac68-057effd91e17"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-01)", "package_ndc": "65862-784-01", "marketing_start_date": "20160421"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-30)", "package_ndc": "65862-784-30", "marketing_start_date": "20160421"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-784-78)  / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (65862-784-10)", "package_ndc": "65862-784-78", "marketing_start_date": "20160421"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-90)", "package_ndc": "65862-784-90", "marketing_start_date": "20160421"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-99)", "package_ndc": "65862-784-99", "marketing_start_date": "20160421"}], "brand_name": "Esomeprazole Magnesium", "product_id": "65862-784_7da643d0-40fb-4ead-8d34-a95c2a8334f7", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "65862-784", "generic_name": "Esomeprazole Magnesium", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE", "strength": "40 mg/1"}], "application_number": "ANDA205606", "marketing_category": "ANDA", "marketing_start_date": "20160421", "listing_expiration_date": "20261231"}