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United States · US · US:70069-815_26a0088b-92d3-4b6b-e063-6394a90a731e
Esomeprazole Magnesium
Orange BookSPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSomerset Therapeutics, LLC
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1170069815101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70069-815-10)
- ndc11700698153030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70069-815-30)
- ndc11700698159090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70069-815-90)
Annotations
Orange Book
A213859
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": "70069-815_26a0088b-92d3-4b6b-e063-6394a90a731e",
"productndc": "70069-815",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "213859",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Nov 18, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "002",
"approval_date": "Nov 18, 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": "ANDA213859",
"marketing_category": "ANDA",
"nonproprietary_name": "Esomeprazole magnesium",
"start_marketing_date": "20230815",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code A02BC05.
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