Back to search
🇺🇸

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

  • ndc11
    5022843710
    1000 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-437-10)
  • ndc11
    5022843730
    30 TABLET, DELAYED RELEASE in 1 BOTTLE (50228-437-30)
  • ndc11
    5022843760
    60 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

Other records sharing ATC code A02BC.

Access this data programmatically

Query Naproxen and esomeprazole magnesium and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.