Naproxen Sodium

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerL.N.K. International, Inc.

CountryUS (United States)

ATC codeG02CC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
5084441711
60 POUCH in 1 CARTON (50844-417-11) / 1 TABLET, FILM COATED in 1 POUCH (50844-417-43)
ndc11
5084441714
500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-14)
ndc11
5084441716
1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-16)
ndc11
5084441719
1 BOTTLE, PLASTIC in 1 CARTON (50844-417-19) / 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5084441722
48 POUCH in 1 CARTON (50844-417-22) / 1 TABLET, FILM COATED in 1 POUCH (50844-417-43)
ndc11
5084441756
25 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-56)
ndc11
5084441798
8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-98)
ndc11
5084441799
8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-417-99)

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": "50844-417_89d3ed35-e75c-41d8-aa99-57cc1fd866d2",
  "productndc": "50844-417",
  "dosage_form": "TABLET, FILM COATED",
  "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 Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204872",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium",
  "start_marketing_date": "20170201",
  "active_numerator_strength": "220"
}

Related drugs

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