esomeprazole magnesium

Generic: esomeprazole magnesium delayed release capsules

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

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium delayed release capsules
Labeler asclemed usa, inc.
Dosage Form CAPSULE, COATED PELLETS
Routes
ORAL
Active Ingredients

esomeprazole magnesium 40 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-227
Product ID 76420-227_23b36bd4-0dbd-366a-e063-6294a90a1565
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 76420227
Hyphenated Format 76420-227

Supplemental Identifiers

RxCUI
606726 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 delayed release capsules (source: ndc)
Application Number ANDA210559 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-30)
  • 60 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-60)
  • 90 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-90)
source: ndc

Packages (3)

76420-227-30 30 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-30) 76420-227-60 60 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-60) 76420-227-90 90 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-90)

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": "23b36bd4-0dbd-366a-e063-6294a90a1565", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606726", "606730"], "spl_set_id": ["85a963c1-9c13-4eb7-826b-08d5a991fe28"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-30)", "package_ndc": "76420-227-30", "marketing_start_date": "20220727"}, {"sample": false, "description": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-60)", "package_ndc": "76420-227-60", "marketing_start_date": "20220727"}, {"sample": false, "description": "90 CAPSULE, COATED PELLETS in 1 BOTTLE (76420-227-90)", "package_ndc": "76420-227-90", "marketing_start_date": "20220727"}], "brand_name": "Esomeprazole magnesium", "product_id": "76420-227_23b36bd4-0dbd-366a-e063-6294a90a1565", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "76420-227", "generic_name": "Esomeprazole magnesium delayed release capsules", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "40 mg/1"}], "application_number": "ANDA210559", "marketing_category": "ANDA", "marketing_start_date": "20210227", "listing_expiration_date": "20261231"}