esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: innovus pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

esomeprazole magnesium dihydrate 20 mg/1

Manufacturer
INNOVUS PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 57483-225
Product ID 57483-225_3d8224e0-9922-4d9b-89c0-280504788f3c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209339
Listing Expiration 2026-12-31
Marketing Start 2023-05-25

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 57483225
Hyphenated Format 57483-225

Supplemental Identifiers

RxCUI
606726
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 ANDA209339 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3 BOTTLE in 1 CARTON (57483-225-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

57483-225-42 3 BOTTLE in 1 CARTON (57483-225-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

esomeprazole magnesium dihydrate (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": "3d8224e0-9922-4d9b-89c0-280504788f3c", "openfda": {"unii": ["36H71644EQ"], "rxcui": ["606726"], "spl_set_id": ["a32039b7-8475-4ec5-abaf-07f9aee3954b"], "manufacturer_name": ["INNOVUS PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (57483-225-42)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "57483-225-42", "marketing_start_date": "20230525"}], "brand_name": "Esomeprazole Magnesium", "product_id": "57483-225_3d8224e0-9922-4d9b-89c0-280504788f3c", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "57483-225", "generic_name": "Esomeprazole Magnesium", "labeler_name": "INNOVUS PHARMACEUTICALS, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA209339", "marketing_category": "ANDA", "marketing_start_date": "20230525", "listing_expiration_date": "20261231"}