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 dihydrate 20 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1368
Product ID 71335-1368_c5e7d732-9f76-42b8-895b-a06495045d18
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206296
Listing Expiration 2026-12-31
Marketing Start 2019-05-30

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 713351368
Hyphenated Format 71335-1368

Supplemental Identifiers

RxCUI
606726
UNII
36H71644EQ

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 ANDA206296 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-1)
  • 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-2)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-3)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-4)
  • 42 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-5)
  • 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-6)
  • 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-7)
  • 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-8)
source: ndc

Packages (8)

71335-1368-1 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-1) 71335-1368-2 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-2) 71335-1368-3 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-3) 71335-1368-4 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-4) 71335-1368-5 42 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-5) 71335-1368-6 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-6) 71335-1368-7 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-7) 71335-1368-8 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-8)

Ingredients (1)

esomeprazole magnesium dihydrate (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": "c5e7d732-9f76-42b8-895b-a06495045d18", "openfda": {"unii": ["36H71644EQ"], "rxcui": ["606726"], "spl_set_id": ["596e1cf8-dc6e-48b0-95ae-b463955870f7"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-1)", "package_ndc": "71335-1368-1", "marketing_start_date": "20191015"}, {"sample": false, "description": "10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-2)", "package_ndc": "71335-1368-2", "marketing_start_date": "20240520"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-3)", "package_ndc": "71335-1368-3", "marketing_start_date": "20240520"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-4)", "package_ndc": "71335-1368-4", "marketing_start_date": "20240520"}, {"sample": false, "description": "42 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-5)", "package_ndc": "71335-1368-5", "marketing_start_date": "20240520"}, {"sample": false, "description": "120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-6)", "package_ndc": "71335-1368-6", "marketing_start_date": "20240520"}, {"sample": false, "description": "180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-7)", "package_ndc": "71335-1368-7", "marketing_start_date": "20240520"}, {"sample": false, "description": "20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1368-8)", "package_ndc": "71335-1368-8", "marketing_start_date": "20240520"}], "brand_name": "esomeprazole magnesium", "product_id": "71335-1368_c5e7d732-9f76-42b8-895b-a06495045d18", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "71335-1368", "generic_name": "esomeprazole magnesium", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "esomeprazole magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE", "strength": "20 mg/1"}], "application_number": "ANDA206296", "marketing_category": "ANDA", "marketing_start_date": "20190530", "listing_expiration_date": "20261231"}