Naproxen Sodium

Orange BookUNIISPLATC G02CC02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerUpsher-Smith Laboratories, LLC

CountryUS (United States)

ATC codeG02CC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2497925406
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-254-06)

Annotations

UNII (FDA Substance ID)

9TN87S3A3C

NAPROXEN SODIUM

RxCUI 142442

Orange Book

N020353

ABABAB

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": "24979-254_a79a3bf0-fe2f-4ba4-8eaa-e1c97ab9b927",
  "productndc": "24979-254",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "020353",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 375MG BASE",
        "product_no": "001",
        "approval_date": "Jan 5, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "002",
        "approval_date": "Jan 5, 1996"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 750MG BASE",
        "product_no": "003",
        "approval_date": "Jan 5, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NAPROXEN SODIUM",
  "proprietary_name": "Naproxen Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020353",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Naproxen Sodium",
  "start_marketing_date": "20240425",
  "active_numerator_strength": "750"
}

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