🇺🇸
United States · US · US:85509-1438_4c25c053-eadd-e346-e063-6394a90afe42
Naproxen and esomeprazole magnesium
Orange BookSPLATC A02BC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPHOENIX RX LLC
CountryUS (United States)
ATC codeA02BC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc118550914381100 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1438-1)
- ndc11855091438330 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1438-3)
- ndc11855091438660 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1438-6)
- ndc11855091438990 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1438-9)
Annotations
Orange Book
A217738
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"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": "85509-1438_4c25c053-eadd-e346-e063-6394a90afe42",
"productndc": "85509-1438",
"dosage_form": "TABLET, DELAYED RELEASE",
"orange_book": {
"appl_no": "217738",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE;375MG",
"product_no": "001",
"approval_date": "Oct 11, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE;500MG",
"product_no": "002",
"approval_date": "Oct 11, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESOMEPRAZOLE MAGNESIUM; NAPROXEN",
"proprietary_name": "Naproxen and esomeprazole magnesium",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA217738",
"marketing_category": "ANDA",
"nonproprietary_name": "Naproxen and esomeprazole magnesium",
"start_marketing_date": "20231011",
"active_numerator_strength": "20; 500"
}Related drugs
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