esomeprazole magnesium delayed-release capsules, 20 mg

Generic: esomeprazole magnesium delayed-release capsules, 20 mg

Labeler: marksans pharma limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium delayed-release capsules, 20 mg
Generic Name esomeprazole magnesium delayed-release capsules, 20 mg
Labeler marksans pharma limited
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium 20 mg/1

Manufacturer
MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-075
Product ID 25000-075_2c8804c8-f28d-4381-ad8b-708009989b57
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA217264
Listing Expiration 2026-12-31
Marketing Start 2023-09-30

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 25000075
Hyphenated Format 25000-075

Supplemental Identifiers

RxCUI
606726
UPC
0325000112769 0325000075767
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 delayed-release capsules, 20 mg (source: ndc)
Generic Name esomeprazole magnesium delayed-release capsules, 20 mg (source: ndc)
Application Number ANDA217264 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (25000-075-76) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

25000-075-76 1 BOTTLE in 1 CARTON (25000-075-76) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

esomeprazole magnesium (20 mg/1)

Linked Drug Pages (1)

Esomeprazole Magnesium Delayed-Release Capsules, 20 mg, Esomeprazole Magnesium Delayed-Release 20 mg mini ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c8804c8-f28d-4381-ad8b-708009989b57", "openfda": {"upc": ["0325000112769", "0325000075767"], "unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["32f26c74-3052-4a69-9dc7-d18f9d761a8b"], "manufacturer_name": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (25000-075-76)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "25000-075-76", "marketing_start_date": "20230930"}], "brand_name": "Esomeprazole Magnesium Delayed-Release Capsules, 20 mg", "product_id": "25000-075_2c8804c8-f28d-4381-ad8b-708009989b57", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "25000-075", "generic_name": "Esomeprazole Magnesium Delayed-Release Capsules, 20 mg", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Esomeprazole Magnesium Delayed-Release Capsules, 20 mg", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA217264", "marketing_category": "ANDA", "marketing_start_date": "20230930", "listing_expiration_date": "20261231"}