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United States · US · US:70000-0738_08980e5c-b70f-43a1-97ec-1b3030a84628
Esomeprazole Magnesium
Orange BookUNIISPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLEADER/ CARDINAL HEALTH 110, INC.
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170000073812 BOTTLE in 1 CARTON (70000-0738-1) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70000-0738-2)
Annotations
UNII (FDA Substance ID)
R6DXU4WAY9
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
RxCUI 283562
Orange Book
A209339
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "R6DXU4WAY9",
"rxcui": "283562",
"inchikey": "VEVZQDGATGBLIC-OXLUMUBXSA-N",
"display_name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"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": "70000-0738_08980e5c-b70f-43a1-97ec-1b3030a84628",
"productndc": "70000-0738",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "209339",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Oct 16, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
"proprietary_name": "Esomeprazole Magnesium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209339",
"marketing_category": "ANDA",
"nonproprietary_name": "Esomeprazole Magnesium",
"start_marketing_date": "20251003",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC05.
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