esomeprazole magnesium

Generic: esomeprazole

Labeler: h e b
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole
Labeler h e b
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole 20 mg/1

Manufacturer
H E B

Identifiers & Regulatory

Product NDC 37808-719
Product ID 37808-719_e03b4775-6fd8-4d45-83e8-bc405104c539
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207193
Listing Expiration 2026-12-31
Marketing Start 2020-08-06

Pharmacologic Class

Established (EPC)
proton pump inhibitor [epc]
Mechanism of Action
proton pump inhibitors [moa] cytochrome p450 2c19 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37808719
Hyphenated Format 37808-719

Supplemental Identifiers

RxCUI
606726
UNII
N3PA6559FT
NUI
N0000175525 N0000000147 N0000182140

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 (source: ndc)
Application Number ANDA207193 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (37808-719-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (37808-719-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

37808-719-01 1 BOTTLE in 1 CARTON (37808-719-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 37808-719-03 3 BOTTLE in 1 CARTON (37808-719-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

esomeprazole (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": "e03b4775-6fd8-4d45-83e8-bc405104c539", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["N3PA6559FT"], "rxcui": ["606726"], "spl_set_id": ["0d08dd06-8df6-43ff-9033-8eebd215bec1"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["H E B"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (37808-719-01)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "37808-719-01", "marketing_start_date": "20200806"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (37808-719-03)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "37808-719-03", "marketing_start_date": "20200806"}], "brand_name": "Esomeprazole Magnesium", "product_id": "37808-719_e03b4775-6fd8-4d45-83e8-bc405104c539", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "37808-719", "generic_name": "esomeprazole", "labeler_name": "H E B", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA207193", "marketing_category": "ANDA", "marketing_start_date": "20200806", "listing_expiration_date": "20261231"}