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 FOR SUSPENSION
Routes
ORAL
Active Ingredients

esomeprazole magnesium dihydrate 5 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-508
Product ID 69097-508_75c5150c-7eab-4f85-9c34-80c0ecb4a07b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217714
Listing Expiration 2026-12-31
Marketing Start 2025-01-07

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 69097508
Hyphenated Format 69097-508

Supplemental Identifiers

RxCUI
1297658 1297761
UNII
36H71644EQ

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 ANDA217714 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 FOR SUSPENSION in 1 CARTON (69097-508-31)
source: ndc

Packages (1)

69097-508-31 30 FOR SUSPENSION in 1 CARTON (69097-508-31)

Ingredients (1)

esomeprazole magnesium dihydrate (5 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": "75c5150c-7eab-4f85-9c34-80c0ecb4a07b", "openfda": {"unii": ["36H71644EQ"], "rxcui": ["1297658", "1297761"], "spl_set_id": ["e89589f1-945e-429a-819e-61755cba77fa"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 FOR SUSPENSION in 1 CARTON (69097-508-31)", "package_ndc": "69097-508-31", "marketing_start_date": "20250107"}], "brand_name": "Esomeprazole magnesium", "product_id": "69097-508_75c5150c-7eab-4f85-9c34-80c0ecb4a07b", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "69097-508", "generic_name": "Esomeprazole magnesium", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE", "strength": "5 mg/1"}], "application_number": "ANDA217714", "marketing_category": "ANDA", "marketing_start_date": "20250107", "listing_expiration_date": "20261231"}