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United States · US · US:71205-595_0193d608-f4a8-5a69-e063-6294a90aafe8

Naproxen

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeG02CC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7120559524
    24 TABLET in 1 BOTTLE (71205-595-24)
  • ndc11
    7120559530
    30 TABLET in 1 BOTTLE (71205-595-30)
  • ndc11
    7120559560
    60 TABLET in 1 BOTTLE (71205-595-60)
  • ndc11
    7120559590
    90 TABLET in 1 BOTTLE (71205-595-90)

Annotations

UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
A204872
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": "71205-595_0193d608-f4a8-5a69-e063-6294a90aafe8",
  "productndc": "71205-595",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204872",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "220MG",
        "product_no": "001",
        "approval_date": "Jan 23, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NAPROXEN SODIUM",
  "proprietary_name": "Naproxen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204872",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium",
  "start_marketing_date": "20190101",
  "active_numerator_strength": "220"
}

Related drugs

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