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United States · US · US:0186-5040_26f66e74-b652-4b1d-bfff-62a3cc87d590
NEXIUM
Orange BookUNIISPLATC A02BC05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeA02BC05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11018650403130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5040-31)
- ndc11018650405490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5040-54)
Annotations
UNII (FDA Substance ID)
R6DXU4WAY9
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
RxCUI 283562
Orange Book
N021153
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": {
"f4853677-1622-4037-688b-fdf533a11d96": {
"match": "brand_token",
"title": "NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]",
"spl_version": "74",
"published_date": "2026-04-13"
}
},
"productid": "0186-5040_26f66e74-b652-4b1d-bfff-62a3cc87d590",
"productndc": "0186-5040",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "021153",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Feb 20, 2001"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "002",
"approval_date": "Feb 20, 2001"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
"proprietary_name": "NEXIUM",
"active_ingred_unit": "mg/1",
"application_number": "NDA021153",
"marketing_category": "NDA",
"nonproprietary_name": "Esomeprazole magnesium",
"start_marketing_date": "20010319",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code A02BC05.
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