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United States · US · US:27854-505_937b99a5-63ed-4f0d-8866-69c60d9743d8

Flanax Pain Reliever/Fever reducer

Orange BookUNIISPLATC G02CC02

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

Identification

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

Packs · 2

  • ndc11
    2785450501
    1 BOTTLE in 1 CARTON (27854-505-01) / 24 TABLET, COATED in 1 BOTTLE
  • ndc11
    2785450502
    1 BOTTLE in 1 CARTON (27854-505-02) / 2 TABLET, COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
9TN87S3A3C
NAPROXEN SODIUM
RxCUI 142442
Orange Book
A090545
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": {
    "2b4135b3-389c-46e2-ae86-7674c2ab9a32": {
      "match": "brand_token",
      "title": "FLANAX MENSTRUAL PAIN RELIEVER (NAPROXEN SODIUM) TABLET, FILM COATED [BELMORA LLC]",
      "spl_version": "15",
      "published_date": "2026-01-28"
    }
  },
  "productid": "27854-505_937b99a5-63ed-4f0d-8866-69c60d9743d8",
  "productndc": "27854-505",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "090545",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "220MG",
        "product_no": "001",
        "approval_date": "Mar 16, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NAPROXEN SODIUM",
  "proprietary_name": "Flanax Pain Reliever/Fever reducer",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090545",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen Sodium",
  "start_marketing_date": "20200515",
  "active_numerator_strength": "220"
}

Related drugs

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