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United States · US · US:53185-394_aa5989d3-2bbf-448d-b90f-ec90849011c1

Naproxen Sodium 220mg

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerAthlete's Needs, Inc.
CountryUS (United States)
ATC codeG02CC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5318539450
    50 TABLET, COATED in 1 BOTTLE (53185-394-50)

Annotations

UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
A090545
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9TN87S3A3C",
    "rxcui": "142442",
    "inchikey": "CDBRNDSHEYLDJV-FVGYRXGTSA-M",
    "display_name": "NAPROXEN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "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": "53185-394_aa5989d3-2bbf-448d-b90f-ec90849011c1",
  "productndc": "53185-394",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "090545",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "220MG",
        "product_no": "001",
        "approval_date": "Mar 16, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NAPROXEN SODIUM",
  "proprietary_name": "Naproxen Sodium 220mg",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090545",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium 220mg",
  "start_marketing_date": "20141223",
  "active_numerator_strength": "220"
}

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