esomeprazole magnesium

Generic: esomeprazole magnesium

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

Drug Facts

Product Profile

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

esomeprazole magnesium 20 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-2350
Product ID 0378-2350_e0389e97-0278-4684-b6b7-d4c19a151f6f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078936
Listing Expiration 2026-12-31
Marketing Start 2015-08-03

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 03782350
Hyphenated Format 0378-2350

Supplemental Identifiers

RxCUI
606726 606730
UPC
0303782350937 0303782351934
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 ANDA078936 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2350-77)
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2350-93)
source: ndc

Packages (2)

0378-2350-77 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2350-77) 0378-2350-93 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2350-93)

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": "e0389e97-0278-4684-b6b7-d4c19a151f6f", "openfda": {"upc": ["0303782350937", "0303782351934"], "unii": ["R6DXU4WAY9"], "rxcui": ["606726", "606730"], "spl_set_id": ["e04e7c84-59c8-4a1d-8dfc-d72588b97b59"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2350-77)", "package_ndc": "0378-2350-77", "marketing_start_date": "20160111"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2350-93)", "package_ndc": "0378-2350-93", "marketing_start_date": "20150803"}], "brand_name": "Esomeprazole Magnesium", "product_id": "0378-2350_e0389e97-0278-4684-b6b7-d4c19a151f6f", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0378-2350", "generic_name": "Esomeprazole Magnesium", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA078936", "marketing_category": "ANDA", "marketing_start_date": "20150803", "listing_expiration_date": "20261231"}