esomeprazole sodium

Generic: esomeprazole sodium

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole sodium
Generic Name esomeprazole sodium
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

esomeprazole sodium 40 mg/5mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-452
Product ID 68083-452_e8d62781-b9de-4d02-b5d2-02b024895c95
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203349
Listing Expiration 2026-12-31
Marketing Start 2020-04-01

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 68083452
Hyphenated Format 68083-452

Supplemental Identifiers

RxCUI
486499 486501
UPC
0368083452100
UNII
L2C9GWQ43H

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 sodium (source: ndc)
Generic Name esomeprazole sodium (source: ndc)
Application Number ANDA203349 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/5mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (68083-452-10) / 5 mL in 1 VIAL (68083-452-01)
source: ndc

Packages (1)

68083-452-10 10 VIAL in 1 CARTON (68083-452-10) / 5 mL in 1 VIAL (68083-452-01)

Ingredients (1)

esomeprazole sodium (40 mg/5mL)

Linked Drug Pages (1)

Esomeprazole Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e8d62781-b9de-4d02-b5d2-02b024895c95", "openfda": {"upc": ["0368083452100"], "unii": ["L2C9GWQ43H"], "rxcui": ["486499", "486501"], "spl_set_id": ["9354958c-e997-41c8-8605-23f0a58993c0"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (68083-452-10)  / 5 mL in 1 VIAL (68083-452-01)", "package_ndc": "68083-452-10", "marketing_start_date": "20200401"}], "brand_name": "Esomeprazole Sodium", "product_id": "68083-452_e8d62781-b9de-4d02-b5d2-02b024895c95", "dosage_form": "INJECTION", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "68083-452", "generic_name": "Esomeprazole Sodium", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole Sodium", "active_ingredients": [{"name": "ESOMEPRAZOLE SODIUM", "strength": "40 mg/5mL"}], "application_number": "ANDA203349", "marketing_category": "ANDA", "marketing_start_date": "20200401", "listing_expiration_date": "20261231"}