esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium dihydrate 40 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8396
Product ID 0615-8396_0300c30b-ed64-4d94-8ccc-c77ea3ad4419
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205606
Marketing Start 2016-04-21
Marketing End 2026-05-31

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 06158396
Hyphenated Format 0615-8396

Supplemental Identifiers

RxCUI
606730
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
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8396-39)
source: ndc

Packages (1)

0615-8396-39 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8396-39)

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": "0300c30b-ed64-4d94-8ccc-c77ea3ad4419", "openfda": {"unii": ["36H71644EQ"], "rxcui": ["606730"], "spl_set_id": ["213ccff1-4982-426b-a4f8-ecb2f2ee6dc6"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8396-39)", "package_ndc": "0615-8396-39", "marketing_end_date": "20260531", "marketing_start_date": "20210622"}], "brand_name": "Esomeprazole Magnesium", "product_id": "0615-8396_0300c30b-ed64-4d94-8ccc-c77ea3ad4419", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0615-8396", "generic_name": "Esomeprazole Magnesium", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "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_end_date": "20260531", "marketing_start_date": "20160421"}