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United States · US · US:80425-0331_2a9b9724-0260-e829-e063-6394a90a1c07
Esomeprazole Magnesium
Orange BookSPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11804250331130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0331-1)
- ndc11804250331260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0331-2)
- ndc11804250331390 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0331-3)
Annotations
Orange Book
A211977
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": "80425-0331_2a9b9724-0260-e829-e063-6394a90a1c07",
"productndc": "80425-0331",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "211977",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Jun 2, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "002",
"approval_date": "Jun 2, 2020"
}
],
"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": "ANDA211977",
"marketing_category": "ANDA",
"nonproprietary_name": "Esomeprazole Magnesium",
"start_marketing_date": "20230502",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code A02BC05.
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