🇺🇸
United States · US · US:80425-0440_25a48082-ca9a-42a4-e063-6394a90ae559
Esomeprazole magnesium
Orange BookSPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11804250440130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0440-1)
- ndc11804250440260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0440-2)
- ndc11804250440390 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0440-3)
Annotations
Orange Book
A217427
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "ORAL",
"spl_meta": {
"6a21f085-b60b-49b7-8098-99ccdc43dde3": {
"match": "brand_token",
"title": "ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG (OTC) CAPSULE, DELAYED RELEASE ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE 20 MG MINI CAPSULE, DELAYED RELEASE [MARKSANS PHARMA LIMITED]",
"spl_version": "3",
"published_date": "2026-06-02"
}
},
"productid": "80425-0440_25a48082-ca9a-42a4-e063-6394a90ae559",
"productndc": "80425-0440",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "217427",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Oct 18, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "002",
"approval_date": "Oct 18, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESOMEPRAZOLE MAGNESIUM",
"proprietary_name": "Esomeprazole magnesium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217427",
"marketing_category": "ANDA",
"nonproprietary_name": "Esomeprazole magnesium",
"start_marketing_date": "20241029",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code A02BC05.
Access this data programmatically
Query Esomeprazole magnesium and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.