Esomeprazole

Generic: Esomeprazole

Labeler: Dexcel Pharma Technologies Ltd
NDC Directory HUMAN OTC DRUG NDA Active

Drug Facts

Product Profile

Brand Name Esomeprazole
Generic Name Esomeprazole
Labeler Dexcel Pharma Technologies Ltd
Dosage Form TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Routes
ORAL
Active Ingredients

ESOMEPRAZOLE 20 mg/1

Identifiers & Regulatory

Product NDC 64239-112
Product ID 64239-112_ac98e06c-0b6a-48f4-9f6d-40b40807b1e5
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA214278
Listing Expiration 2026-12-31
Marketing Start 2024-04-12

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64239112
Hyphenated Format 64239-112

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 (source: ndc)
Generic Name Esomeprazole (source: ndc)
Application Number NDA214278 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (64239-112-02) / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
  • 2 CARTON in 1 CARTON (64239-112-03) / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
  • 3 CARTON in 1 CARTON (64239-112-04) / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (64239-112-05) / 2 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (64239-112-07) / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
  • 2 CARTON in 1 CARTON (64239-112-08) / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
  • 3 CARTON in 1 CARTON (64239-112-09) / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (64239-112-10) / 2 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (8)

64239-112-02 2 BLISTER PACK in 1 CARTON (64239-112-02) / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK 64239-112-03 2 CARTON in 1 CARTON (64239-112-03) / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK 64239-112-04 3 CARTON in 1 CARTON (64239-112-04) / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK 64239-112-05 1 BLISTER PACK in 1 CARTON (64239-112-05) / 2 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK 64239-112-07 2 BLISTER PACK in 1 CARTON (64239-112-07) / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK 64239-112-08 2 CARTON in 1 CARTON (64239-112-08) / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK 64239-112-09 3 CARTON in 1 CARTON (64239-112-09) / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK 64239-112-10 1 BLISTER PACK in 1 CARTON (64239-112-10) / 2 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK

Ingredients (1)

ESOMEPRAZOLE (20 mg/1)

Linked Drug Pages (1)

Esomeprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ac98e06c-0b6a-48f4-9f6d-40b40807b1e5", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["N3PA6559FT"], "rxcui": ["2679449"], "spl_set_id": ["3922a971-b371-4159-8c34-369798809965"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Dexcel Pharma Technologies Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (64239-112-02)  / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "64239-112-02", "marketing_start_date": "20240412"}, {"sample": false, "description": "2 CARTON in 1 CARTON (64239-112-03)  / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "64239-112-03", "marketing_start_date": "20240412"}, {"sample": false, "description": "3 CARTON in 1 CARTON (64239-112-04)  / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "64239-112-04", "marketing_start_date": "20240412"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (64239-112-05)  / 2 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "64239-112-05", "marketing_start_date": "20240412"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (64239-112-07)  / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "64239-112-07", "marketing_start_date": "20240412"}, {"sample": false, "description": "2 CARTON in 1 CARTON (64239-112-08)  / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "64239-112-08", "marketing_start_date": "20240412"}, {"sample": false, "description": "3 CARTON in 1 CARTON (64239-112-09)  / 2 BLISTER PACK in 1 CARTON / 7 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "64239-112-09", "marketing_start_date": "20240412"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (64239-112-10)  / 2 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "64239-112-10", "marketing_start_date": "20240412"}], "brand_name": "Esomeprazole", "product_id": "64239-112_ac98e06c-0b6a-48f4-9f6d-40b40807b1e5", "dosage_form": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "64239-112", "generic_name": "Esomeprazole", "labeler_name": "Dexcel Pharma Technologies Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Esomeprazole", "active_ingredients": [{"name": "ESOMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "NDA214278", "marketing_category": "NDA", "marketing_start_date": "20240412", "listing_expiration_date": "20261231"}