esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: little pharma, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

esomeprazole magnesium 20 mg/1

Manufacturer
LITTLE PHARMA, INC.

Identifiers & Regulatory

Product NDC 72559-011
Product ID 72559-011_1b1a0d42-2f12-fb82-e063-6394a90af12f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212866
Listing Expiration 2026-12-31
Marketing Start 2021-03-23

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 72559011
Hyphenated Format 72559-011

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 magnesium (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 (72559-011-06) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72559-011-07)
  • 4 CARTON in 1 PACKAGE, COMBINATION (72559-011-36) / 3 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (3)

72559-011-06 3 BOTTLE in 1 CARTON (72559-011-06) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 72559-011-07 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72559-011-07) 72559-011-36 4 CARTON in 1 PACKAGE, COMBINATION (72559-011-36) / 3 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

esomeprazole magnesium (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": "1b1a0d42-2f12-fb82-e063-6394a90af12f", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["e45621ea-cc15-4a8e-98d2-d10ab424a45e"], "manufacturer_name": ["LITTLE PHARMA, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (72559-011-06)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "72559-011-06", "marketing_start_date": "20210323"}, {"sample": false, "description": "14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72559-011-07)", "package_ndc": "72559-011-07", "marketing_start_date": "20210323"}, {"sample": false, "description": "4 CARTON in 1 PACKAGE, COMBINATION (72559-011-36)  / 3 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "72559-011-36", "marketing_start_date": "20240618"}], "brand_name": "Esomeprazole Magnesium", "product_id": "72559-011_1b1a0d42-2f12-fb82-e063-6394a90af12f", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "72559-011", "generic_name": "Esomeprazole Magnesium", "labeler_name": "LITTLE PHARMA, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA212866", "marketing_category": "ANDA", "marketing_start_date": "20210323", "listing_expiration_date": "20261231"}