🇺🇸
United States · US · US:82804-276_5fd008ef-8388-48e9-8d38-76e0106bd5b6
Naproxen and esomeprazole magnesium
Orange BookUNIISPLATC A02BC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeA02BC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11828042766060 TABLET, DELAYED RELEASE in 1 BOTTLE (82804-276-60)
Annotations
UNII (FDA Substance ID)
R6DXU4WAY9
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
RxCUI 283562
Orange Book
A213699
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": {
"c5146d73-2f34-4dfe-ac29-97071279dc4d": {
"match": "brand_token",
"title": "NAPROXEN SODIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
"spl_version": "10",
"published_date": "2026-05-28"
}
},
"productid": "82804-276_5fd008ef-8388-48e9-8d38-76e0106bd5b6",
"productndc": "82804-276",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "213699",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE;375MG",
"product_no": "001",
"approval_date": "Oct 6, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE;500MG",
"product_no": "002",
"approval_date": "Oct 6, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAPROXEN",
"proprietary_name": "Naproxen and esomeprazole magnesium",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA213699",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen and esomeprazole magnesium",
"start_marketing_date": "20221006",
"active_numerator_strength": "20; 500"
}Related drugs
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