esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler remedyrepack inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium 40 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3850
Product ID 70518-3850_3f8bdbae-36f1-9e7a-e063-6294a90ac847
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213486
Listing Expiration 2026-12-31
Marketing Start 2023-09-02

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 705183850
Hyphenated Format 70518-3850

Supplemental Identifiers

RxCUI
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 (source: ndc)
Application Number ANDA213486 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3850-0)
source: ndc

Packages (1)

70518-3850-0 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3850-0)

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": "3f8bdbae-36f1-9e7a-e063-6294a90ac847", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["606730"], "spl_set_id": ["e6e1906f-60be-402f-97f4-6d7bea1a6c08"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3850-0)", "package_ndc": "70518-3850-0", "marketing_start_date": "20230902"}], "brand_name": "esomeprazole magnesium", "product_id": "70518-3850_3f8bdbae-36f1-9e7a-e063-6294a90ac847", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "70518-3850", "generic_name": "esomeprazole magnesium", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "esomeprazole magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "40 mg/1"}], "application_number": "ANDA213486", "marketing_category": "ANDA", "marketing_start_date": "20230902", "listing_expiration_date": "20261231"}