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United States · US · US:46122-564_df535323-45f6-489b-81fe-009ca024499d

Naproxen

Orange BookUNIISPLATC G02CC02

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

Identification

ManufacturerAmerisource Bergen
CountryUS (United States)
ATC codeG02CC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4612256471
    1 BOTTLE, PLASTIC in 1 CARTON (46122-564-71) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    4612256478
    1 BOTTLE, PLASTIC in 1 CARTON (46122-564-78) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    4612256481
    200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46122-564-81)

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": "46122-564_df535323-45f6-489b-81fe-009ca024499d",
  "productndc": "46122-564",
  "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",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204872",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium",
  "start_marketing_date": "20190201",
  "active_numerator_strength": "220"
}

Related drugs

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