esomeprazole magnesium

Generic: esomeprazole magnesium

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

Drug Facts

Product Profile

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

esomeprazole magnesium 20 mg/1

Manufacturer
H E B

Identifiers & Regulatory

Product NDC 37808-364
Product ID 37808-364_eeab6a1c-15f1-740c-1aa8-794b54e7d9c0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207198
Listing Expiration 2026-12-31
Marketing Start 2025-03-01

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 37808364
Hyphenated Format 37808-364

Supplemental Identifiers

RxCUI
606726
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 (source: ndc)
Application Number ANDA207198 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (37808-364-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (37808-364-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (37808-364-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (3)

37808-364-14 1 BOTTLE in 1 CARTON (37808-364-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 37808-364-28 2 BOTTLE in 1 CARTON (37808-364-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE 37808-364-42 3 BOTTLE in 1 CARTON (37808-364-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

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": "eeab6a1c-15f1-740c-1aa8-794b54e7d9c0", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["a5a6f614-2920-d74c-1ddc-9a07a0ec6e05"], "manufacturer_name": ["H E B"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (37808-364-14)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "37808-364-14", "marketing_start_date": "20250301"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (37808-364-28)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "37808-364-28", "marketing_start_date": "20250301"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (37808-364-42)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "37808-364-42", "marketing_start_date": "20250301"}], "brand_name": "Esomeprazole Magnesium", "product_id": "37808-364_eeab6a1c-15f1-740c-1aa8-794b54e7d9c0", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "37808-364", "generic_name": "Esomeprazole Magnesium", "labeler_name": "H E B", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Esomeprazole Magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA207198", "marketing_category": "ANDA", "marketing_start_date": "20250301", "listing_expiration_date": "20261231"}