esomeprazole magnesium

Generic: esomeprazole magnesium delayed release capsules

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

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium delayed release capsules
Labeler bryant ranch prepack
Dosage Form CAPSULE, COATED PELLETS
Routes
ORAL
Active Ingredients

esomeprazole magnesium 20 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-9678
Product ID 71335-9678_e5116491-c738-4e54-9383-d8a4c7494fa0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210559
Listing Expiration 2026-12-31
Marketing Start 2021-02-27

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 713359678
Hyphenated Format 71335-9678

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 delayed release capsules (source: ndc)
Application Number ANDA210559 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-1)
  • 10 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-2)
  • 60 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-3)
  • 90 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-4)
  • 42 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-5)
  • 120 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-6)
  • 180 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-7)
  • 20 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-8)
source: ndc

Packages (8)

71335-9678-1 30 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-1) 71335-9678-2 10 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-2) 71335-9678-3 60 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-3) 71335-9678-4 90 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-4) 71335-9678-5 42 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-5) 71335-9678-6 120 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-6) 71335-9678-7 180 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-7) 71335-9678-8 20 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-8)

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": "e5116491-c738-4e54-9383-d8a4c7494fa0", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["db8a346e-dba1-41bc-b122-a1de868ee91a"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-1)", "package_ndc": "71335-9678-1", "marketing_start_date": "20230517"}, {"sample": false, "description": "10 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-2)", "package_ndc": "71335-9678-2", "marketing_start_date": "20240530"}, {"sample": false, "description": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-3)", "package_ndc": "71335-9678-3", "marketing_start_date": "20230323"}, {"sample": false, "description": "90 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-4)", "package_ndc": "71335-9678-4", "marketing_start_date": "20240530"}, {"sample": false, "description": "42 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-5)", "package_ndc": "71335-9678-5", "marketing_start_date": "20240530"}, {"sample": false, "description": "120 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-6)", "package_ndc": "71335-9678-6", "marketing_start_date": "20240530"}, {"sample": false, "description": "180 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-7)", "package_ndc": "71335-9678-7", "marketing_start_date": "20240530"}, {"sample": false, "description": "20 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-8)", "package_ndc": "71335-9678-8", "marketing_start_date": "20240530"}], "brand_name": "Esomeprazole magnesium", "product_id": "71335-9678_e5116491-c738-4e54-9383-d8a4c7494fa0", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "71335-9678", "generic_name": "Esomeprazole magnesium delayed release capsules", "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": "ANDA210559", "marketing_category": "ANDA", "marketing_start_date": "20210227", "listing_expiration_date": "20261231"}