esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler bryant ranch prepack
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium 20 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2018
Product ID 71335-2018_d95a3df7-b940-4a73-8238-3608e58ca70b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211977
Listing Expiration 2026-12-31
Marketing Start 2020-06-02

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 713352018
Hyphenated Format 71335-2018

Supplemental Identifiers

RxCUI
606726
UNII
R6DXU4WAY9

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 ANDA211977 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-1)
  • 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-2)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-3)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-4)
  • 42 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-5)
  • 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-6)
  • 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-7)
  • 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-8)
source: ndc

Packages (8)

71335-2018-1 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-1) 71335-2018-2 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-2) 71335-2018-3 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-3) 71335-2018-4 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-4) 71335-2018-5 42 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-5) 71335-2018-6 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-6) 71335-2018-7 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-7) 71335-2018-8 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-8)

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": "d95a3df7-b940-4a73-8238-3608e58ca70b", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["7778bf7c-52f7-44b3-ac2c-e5a25f6967b7"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-1)", "package_ndc": "71335-2018-1", "marketing_start_date": "20220210"}, {"sample": false, "description": "10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-2)", "package_ndc": "71335-2018-2", "marketing_start_date": "20220210"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-3)", "package_ndc": "71335-2018-3", "marketing_start_date": "20220210"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-4)", "package_ndc": "71335-2018-4", "marketing_start_date": "20220210"}, {"sample": false, "description": "42 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-5)", "package_ndc": "71335-2018-5", "marketing_start_date": "20220210"}, {"sample": false, "description": "120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-6)", "package_ndc": "71335-2018-6", "marketing_start_date": "20220210"}, {"sample": false, "description": "180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-7)", "package_ndc": "71335-2018-7", "marketing_start_date": "20220210"}, {"sample": false, "description": "20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-8)", "package_ndc": "71335-2018-8", "marketing_start_date": "20220210"}], "brand_name": "Esomeprazole Magnesium", "product_id": "71335-2018_d95a3df7-b940-4a73-8238-3608e58ca70b", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "71335-2018", "generic_name": "Esomeprazole Magnesium", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA211977", "marketing_category": "ANDA", "marketing_start_date": "20200602", "listing_expiration_date": "20261231"}