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United States · US · US:76420-889_2a4fb535-ba1a-05d6-e063-6394a90a0b29

Naproxen and esomeprazole magnesium

Orange BookSPLATC A02BC

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeA02BC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7642088901
    100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-01)
  • ndc11
    7642088930
    30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-30)
  • ndc11
    7642088960
    60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-60)
  • ndc11
    7642088990
    90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-90)

Annotations

Orange Book
A204206
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": "76420-889_2a4fb535-ba1a-05d6-e063-6394a90a0b29",
  "productndc": "76420-889",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "204206",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE;375MG",
        "product_no": "001",
        "approval_date": "Feb 18, 2020"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE;500MG",
        "product_no": "002",
        "approval_date": "Feb 18, 2020"
      }
    ],
    "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": "ANDA204206",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen and esomeprazole magnesium",
  "start_marketing_date": "20200218",
  "active_numerator_strength": "20; 500"
}

Related drugs

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