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United States · US · US:43547-001_3d2a1a0f-c770-4f46-851e-0697e4f5de4c
Esomeprazole magnesium
Orange BookUNIISPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSolco Healthcare US LLC
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11435470010330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-001-03)
- ndc11435470010990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-001-09)
Annotations
UNII (FDA Substance ID)
R6DXU4WAY9
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
RxCUI 283562
Orange Book
A214920
ABAB
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": "43547-001_3d2a1a0f-c770-4f46-851e-0697e4f5de4c",
"productndc": "43547-001",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "214920",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Mar 28, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "002",
"approval_date": "Mar 28, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
"proprietary_name": "Esomeprazole magnesium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA214920",
"marketing_category": "ANDA",
"nonproprietary_name": "Esomeprazole magnesium",
"start_marketing_date": "20230328",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A02BC05.
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