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United States · US · US:27241-202_da976bfa-7910-489a-bfc1-3944dfc597e4
Naproxen and esomeprazole magnesium
Orange BookSPLATC A02BC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAjanta Pharma USA Inc.
CountryUS (United States)
ATC codeA02BC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11272412026060 TABLET, DELAYED RELEASE in 1 BOTTLE (27241-202-60)
Annotations
Orange Book
A213699
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": "27241-202_da976bfa-7910-489a-bfc1-3944dfc597e4",
"productndc": "27241-202",
"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; 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; 375"
}Related drugs
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