esomeprazole

Generic: esomeprazole magnesium

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

Drug Facts

Product Profile

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

esomeprazole magnesium trihydrate 20 mg/1

Manufacturer
INNOVUS PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 57483-900
Product ID 57483-900_8f25bf5e-bf0d-413e-8f91-d3537939592b
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212866
Listing Expiration 2026-12-31
Marketing Start 2020-08-14

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 57483900
Hyphenated Format 57483-900

Supplemental Identifiers

RxCUI
606726
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 (source: ndc)
Generic Name esomeprazole magnesium (source: ndc)
Application Number ANDA212866 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3 BOTTLE in 1 CARTON (57483-900-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

57483-900-42 3 BOTTLE in 1 CARTON (57483-900-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

esomeprazole magnesium trihydrate (20 mg/1)

Linked Drug Pages (1)

Esomeprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8f25bf5e-bf0d-413e-8f91-d3537939592b", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["b3d10f0b-52af-408c-9b3d-f8f25f7c42bd"], "manufacturer_name": ["INNOVUS PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (57483-900-42)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "57483-900-42", "marketing_start_date": "20200814"}], "brand_name": "Esomeprazole", "product_id": "57483-900_8f25bf5e-bf0d-413e-8f91-d3537939592b", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "57483-900", "generic_name": "esomeprazole magnesium", "labeler_name": "INNOVUS PHARMACEUTICALS, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Esomeprazole", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA212866", "marketing_category": "ANDA", "marketing_start_date": "20200814", "listing_expiration_date": "20261231"}