🇺🇸
United States · US · US:50228-437_2faf3061-f567-a5dc-e063-6294a90aff8b
Naproxen and esomeprazole magnesium
Orange BookSPLATC A02BC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerScieGen Pharmaceuticals, Inc
CountryUS (United States)
ATC codeA02BC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1150228437101000 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-437-10)
- ndc11502284373030 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-437-30)
- ndc11502284376060 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-437-60)
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": "50228-437_2faf3061-f567-a5dc-e063-6294a90aff8b",
"productndc": "50228-437",
"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; 375"
}Related drugs
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