esomeprazole magnesium

Generic: esomeprazole magnesium

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

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler cipla usa inc.
Dosage Form GRANULE, FOR SUSPENSION, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium 10 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-527
Product ID 69097-527_95dea6c3-8880-42b2-a2d4-8cf93629127e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211752
Listing Expiration 2026-12-31
Marketing Start 2020-03-24

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 69097527
Hyphenated Format 69097-527

Supplemental Identifiers

RxCUI
861568
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 ANDA211752 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 GRANULE, FOR SUSPENSION, EXTENDED RELEASE in 1 CARTON (69097-527-34)
source: ndc

Packages (1)

69097-527-34 30 GRANULE, FOR SUSPENSION, EXTENDED RELEASE in 1 CARTON (69097-527-34)

Ingredients (1)

esomeprazole magnesium (10 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": "95dea6c3-8880-42b2-a2d4-8cf93629127e", "openfda": {"unii": ["R6DXU4WAY9"], "rxcui": ["861568"], "spl_set_id": ["180490d1-c165-4bb9-96b1-12e727256e4e"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 GRANULE, FOR SUSPENSION, EXTENDED RELEASE in 1 CARTON (69097-527-34)", "package_ndc": "69097-527-34", "marketing_start_date": "20200324"}], "brand_name": "ESOMEPRAZOLE MAGNESIUM", "product_id": "69097-527_95dea6c3-8880-42b2-a2d4-8cf93629127e", "dosage_form": "GRANULE, FOR SUSPENSION, EXTENDED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "69097-527", "generic_name": "ESOMEPRAZOLE MAGNESIUM", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ESOMEPRAZOLE MAGNESIUM", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM", "strength": "10 mg/1"}], "application_number": "ANDA211752", "marketing_category": "ANDA", "marketing_start_date": "20200324", "listing_expiration_date": "20261231"}