esomeprazole magnesium

Generic: esomeprazole magnesium

Labeler: solco healthcare us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name esomeprazole magnesium
Generic Name esomeprazole magnesium
Labeler solco healthcare us llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

esomeprazole magnesium trihydrate 40 mg/1

Manufacturer
Solco Healthcare US LLC

Identifiers & Regulatory

Product NDC 43547-002
Product ID 43547-002_3d2a1a0f-c770-4f46-851e-0697e4f5de4c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214920
Listing Expiration 2026-12-31
Marketing Start 2023-03-28

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 43547002
Hyphenated Format 43547-002

Supplemental Identifiers

RxCUI
606726 606730
UPC
0343547001032 0343547002039
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 ANDA214920 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-03)
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-09)
  • 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-11)
source: ndc

Packages (3)

43547-002-03 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-03) 43547-002-09 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-09) 43547-002-11 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-11)

Ingredients (1)

esomeprazole magnesium trihydrate (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": "3d2a1a0f-c770-4f46-851e-0697e4f5de4c", "openfda": {"upc": ["0343547001032", "0343547002039"], "unii": ["R6DXU4WAY9"], "rxcui": ["606726", "606730"], "spl_set_id": ["3cd80c04-43a2-4be3-b831-ebccc273a0d2"], "manufacturer_name": ["Solco Healthcare US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-03)", "package_ndc": "43547-002-03", "marketing_start_date": "20230328"}, {"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-09)", "package_ndc": "43547-002-09", "marketing_start_date": "20230328"}, {"sample": false, "description": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-11)", "package_ndc": "43547-002-11", "marketing_start_date": "20230328"}], "brand_name": "Esomeprazole magnesium", "product_id": "43547-002_3d2a1a0f-c770-4f46-851e-0697e4f5de4c", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "43547-002", "generic_name": "Esomeprazole magnesium", "labeler_name": "Solco Healthcare US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Esomeprazole magnesium", "active_ingredients": [{"name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE", "strength": "40 mg/1"}], "application_number": "ANDA214920", "marketing_category": "ANDA", "marketing_start_date": "20230328", "listing_expiration_date": "20261231"}