esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: reliable 1 laboratories llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler reliable 1 laboratories llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium 20 mg/1

Manufacturer
Reliable 1 Laboratories LLC

Identifiers & Regulatory

Product NDC 69618-073
Product ID 69618-073_7b9c7db0-8cc4-4e45-9715-69be0c208ca5
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA216349
Listing Expiration 2026-12-31
Marketing Start 2023-04-14

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 69618073
Hyphenated Format 69618-073

Supplemental Identifiers

RxCUI
606726
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 ANDA216349 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 3 BOTTLE in 1 CARTON (69618-073-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (1)

69618-073-42 3 BOTTLE in 1 CARTON (69618-073-42) / 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": "7b9c7db0-8cc4-4e45-9715-69be0c208ca5", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606726"], "spl_set_id": ["15d2c4f7-5b20-4c7c-b2a6-9baed7bf39cf"], "manufacturer_name": ["Reliable 1 Laboratories LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BOTTLE in 1 CARTON (69618-073-42)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "69618-073-42", "marketing_start_date": "20230414"}], "brand_name": "ESOMEPRAZOLE MAGNESIUM", "product_id": "69618-073_7b9c7db0-8cc4-4e45-9715-69be0c208ca5", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "69618-073", "generic_name": "ESOMEPRAZOLE MAGNESIUM", "labeler_name": "Reliable 1 Laboratories LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ESOMEPRAZOLE MAGNESIUM", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA216349", "marketing_category": "ANDA", "marketing_start_date": "20230414", "listing_expiration_date": "20261231"}