Diclofenac Epolamine

Orange BookUNIISPLATC D11AX

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

Identification

ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC

CountryUS (United States)

ATC codeD11AX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8042504031
6 POUCH in 1 CARTON (80425-0403-1) / 5 SYSTEM in 1 POUCH

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": {
    "86461915-9bc1-43d4-8d92-6eef3e56bd90": {
      "match": "brand_token",
      "title": "DICLOFENAC POTASSIUM TABLET, COATED [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-06-01"
    }
  },
  "productid": "80425-0403_1b563e42-3b07-5320-e063-6294a90a30e5",
  "productndc": "80425-0403",
  "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": "Diclofenac Epolamine",
  "active_ingred_unit": "g/1",
  "application_number": "NDA021234",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Diclofenac Epolamine",
  "start_marketing_date": "20240619",
  "active_numerator_strength": ".013"
}

Related drugs

Other records sharing ATC code D11AX.

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