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United States · US · US:71858-0405_41a95307-60af-f937-e063-6394a90aa82a

FLECTOR

Orange BookUNIISPLATC D11AX

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

Identification

ManufacturerIBSA Pharma Inc.
CountryUS (United States)
ATC codeD11AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7185804052
    1 POUCH in 1 CARTON (71858-0405-2) / 2 SYSTEM in 1 POUCH (71858-0405-1)
  • ndc11
    7185804055
    6 POUCH in 1 CARTON (71858-0405-5) / 5 SYSTEM in 1 POUCH (71858-0405-4)
  • ndc11
    7185804056
    3 POUCH in 1 CARTON (71858-0405-6) / 5 SYSTEM in 1 POUCH (71858-0405-4)

Annotations

UNII (FDA Substance ID)
X5F8EKL9ZG
DICLOFENAC EPOLAMINE
RxCUI 40968
Orange Book
N021234
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "X5F8EKL9ZG",
    "rxcui": "40968",
    "inchikey": "DCERVXIINVUMKU-UHFFFAOYSA-N",
    "display_name": "DICLOFENAC EPOLAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "1f19a016-c4fc-43c5-9990-e5f2e2776a82": {
      "match": "brand_token",
      "title": "FLECTOR (DICLOFENAC EPOLAMINE) SYSTEM [IBSA PHARMA INC.]",
      "spl_version": "11",
      "published_date": "2025-11-17"
    }
  },
  "productid": "71858-0405_41a95307-60af-f937-e063-6394a90aa82a",
  "productndc": "71858-0405",
  "dosage_form": "SYSTEM",
  "orange_book": {
    "appl_no": "021234",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.3%",
        "product_no": "001",
        "approval_date": "Jan 31, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DICLOFENAC EPOLAMINE",
  "proprietary_name": "FLECTOR",
  "active_ingred_unit": "g/1",
  "application_number": "NDA021234",
  "marketing_category": "NDA",
  "nonproprietary_name": "diclofenac epolamine",
  "start_marketing_date": "20201101",
  "active_numerator_strength": ".013"
}

Related drugs

Other records sharing ATC code D11AX.

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