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United States · US · US:57483-900_8f25bf5e-bf0d-413e-8f91-d3537939592b
Esomeprazole
Orange BookUNIISPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerINNOVUS PHARMACEUTICALS, INC.
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1157483900423 BOTTLE in 1 CARTON (57483-900-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
R6DXU4WAY9
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
RxCUI 283562
Orange Book
A212866
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": "57483-900_8f25bf5e-bf0d-413e-8f91-d3537939592b",
"productndc": "57483-900",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "212866",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "May 4, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
"proprietary_name": "Esomeprazole",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212866",
"marketing_category": "ANDA",
"nonproprietary_name": "esomeprazole magnesium",
"start_marketing_date": "20200814",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC05.
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