esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

esomeprazole magnesium trihydrate 40 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8524
Product ID 68788-8524_efc27899-0425-4367-80ea-3045c6eb59f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213486
Listing Expiration 2026-12-31
Marketing Start 2023-09-14

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 687888524
Hyphenated Format 68788-8524

Supplemental Identifiers

RxCUI
606730
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 ANDA213486 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-1)
  • 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-2)
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-3)
  • 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-6)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-9)
source: ndc

Packages (5)

68788-8524-1 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-1) 68788-8524-2 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-2) 68788-8524-3 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-3) 68788-8524-6 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-6) 68788-8524-9 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-9)

Ingredients (1)

esomeprazole magnesium trihydrate (40 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": "efc27899-0425-4367-80ea-3045c6eb59f5", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606730"], "spl_set_id": ["2d21ed0b-a089-46f4-9ebb-f24f9f3af61d"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-1)", "package_ndc": "68788-8524-1", "marketing_start_date": "20230914"}, {"sample": false, "description": "20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-2)", "package_ndc": "68788-8524-2", "marketing_start_date": "20230914"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-3)", "package_ndc": "68788-8524-3", "marketing_start_date": "20230914"}, {"sample": false, "description": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-6)", "package_ndc": "68788-8524-6", "marketing_start_date": "20230914"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-9)", "package_ndc": "68788-8524-9", "marketing_start_date": "20230914"}], "brand_name": "esomeprazole magnesium", "product_id": "68788-8524_efc27899-0425-4367-80ea-3045c6eb59f5", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "68788-8524", "generic_name": "esomeprazole magnesium", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "esomeprazole magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE", "strength": "40 mg/1"}], "application_number": "ANDA213486", "marketing_category": "ANDA", "marketing_start_date": "20230914", "listing_expiration_date": "20261231"}