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United States · US · US:50844-471_831bfaae-6043-4bb8-9ca2-0ec4043040a7

Naproxen Headache Pain

Orange BookUNIISPLATC G02CC02

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

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
    5084447111
    60 POUCH in 1 CARTON (50844-471-11) / 1 TABLET, FILM COATED in 1 POUCH (50844-471-43)
  • ndc11
    5084447114
    500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-471-14)
  • ndc11
    5084447116
    1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-471-16)
  • ndc11
    5084447119
    1 BOTTLE, PLASTIC in 1 CARTON (50844-471-19) / 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084447122
    48 POUCH in 1 CARTON (50844-471-22) / 1 TABLET, FILM COATED in 1 POUCH (50844-471-43)
  • ndc11
    5084447156
    25 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-471-56)
  • ndc11
    5084447198
    8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-471-98)
  • ndc11
    5084447199
    8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-471-99)

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": "50844-471_831bfaae-6043-4bb8-9ca2-0ec4043040a7",
  "productndc": "50844-471",
  "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 Headache Pain",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204872",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium",
  "start_marketing_date": "20200916",
  "active_numerator_strength": "220"
}

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