Esomeprazole Magnesium

Generic: Esomeprazole Magnesium

Labeler: Quality Care Products, LLC
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name Esomeprazole Magnesium
Generic Name Esomeprazole Magnesium
Labeler Quality Care Products, LLC
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

ESOMEPRAZOLE MAGNESIUM 40 mg/1

Identifiers & Regulatory

Product NDC 83008-016
Product ID 83008-016_17b07449-69eb-4c2e-b0d5-2e5faf8ba755
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211977
Marketing Start 2023-03-16
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83008016
Hyphenated Format 83008-016

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 ANDA211977 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (83008-016-30)
source: ndc

Packages (1)

83008-016-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (83008-016-30)

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": "17b07449-69eb-4c2e-b0d5-2e5faf8ba755", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606730"], "spl_set_id": ["a66aa661-c726-411c-9cb6-4ed41823e2eb"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (83008-016-30)", "package_ndc": "83008-016-30", "marketing_end_date": "20260228", "marketing_start_date": "20230316"}], "brand_name": "Esomeprazole Magnesium", "product_id": "83008-016_17b07449-69eb-4c2e-b0d5-2e5faf8ba755", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "83008-016", "generic_name": "Esomeprazole Magnesium", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "40 mg/1"}], "application_number": "ANDA211977", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20230316"}