esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

esomeprazole magnesium 40 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-034
Product ID 82009-034_af9a0697-ca95-405e-8b81-ec8b38a034f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213486
Listing Expiration 2026-12-31
Marketing Start 2022-12-01

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 82009034
Hyphenated Format 82009-034

Supplemental Identifiers

RxCUI
606726 606730
UPC
0382009034904 0382009033105
UNII
R6DXU4WAY9

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 ANDA213486 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-034-10)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-034-90)
source: ndc

Packages (2)

82009-034-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-034-10) 82009-034-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-034-90)

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": "af9a0697-ca95-405e-8b81-ec8b38a034f3", "openfda": {"upc": ["0382009034904", "0382009033105"], "unii": ["R6DXU4WAY9"], "rxcui": ["606726", "606730"], "spl_set_id": ["7362f930-0879-451e-8de9-8bb8565bfb7e"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-034-10)", "package_ndc": "82009-034-10", "marketing_start_date": "20221201"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-034-90)", "package_ndc": "82009-034-90", "marketing_start_date": "20221201"}], "brand_name": "ESOMEPRAZOLE MAGNESIUM", "product_id": "82009-034_af9a0697-ca95-405e-8b81-ec8b38a034f3", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "82009-034", "generic_name": "ESOMEPRAZOLE MAGNESIUM", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ESOMEPRAZOLE MAGNESIUM", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "40 mg/1"}], "application_number": "ANDA213486", "marketing_category": "ANDA", "marketing_start_date": "20221201", "listing_expiration_date": "20261231"}