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United States · US · US:63629-4873_dd211d96-adc0-4c15-bcf9-6469949add0c

Naproxen and esomeprazole magnesium

Orange BookSPLATC A02BC

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeA02BC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6362948731
    60 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4873-1)
  • ndc11
    6362948732
    30 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4873-2)

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": "63629-4873_dd211d96-adc0-4c15-bcf9-6469949add0c",
  "productndc": "63629-4873",
  "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; 500"
}

Related drugs

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