esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

esomeprazole magnesium 40 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-391
Product ID 68462-391_5eef4592-c7ef-454c-88a9-62671fff9088
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209495
Listing Expiration 2026-12-31
Marketing Start 2021-11-01

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 68462391
Hyphenated Format 68462-391

Supplemental Identifiers

RxCUI
606726 606730
UPC
0368462391303 0368462390306
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 ANDA209495 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-10)
  • 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-30)
  • 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-90)
source: ndc

Packages (3)

68462-391-10 1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-10) 68462-391-30 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-30) 68462-391-90 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-90)

Ingredients (1)

esomeprazole magnesium (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": "5eef4592-c7ef-454c-88a9-62671fff9088", "openfda": {"upc": ["0368462391303", "0368462390306"], "unii": ["R6DXU4WAY9"], "rxcui": ["606726", "606730"], "spl_set_id": ["a6430045-ae60-4a16-92b9-2975cb497629"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-10)", "package_ndc": "68462-391-10", "marketing_start_date": "20211101"}, {"sample": false, "description": "30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-30)", "package_ndc": "68462-391-30", "marketing_start_date": "20211101"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-391-90)", "package_ndc": "68462-391-90", "marketing_start_date": "20211101"}], "brand_name": "Esomeprazole Magnesium", "product_id": "68462-391_5eef4592-c7ef-454c-88a9-62671fff9088", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "68462-391", "generic_name": "Esomeprazole Magnesium", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "40 mg/1"}], "application_number": "ANDA209495", "marketing_category": "ANDA", "marketing_start_date": "20211101", "listing_expiration_date": "20261231"}