Diclofenac Sodium Gel

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerDirect_Rx

CountryUS (United States)

ATC codeM01AB55

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7218937901
1 g in 1 TUBE (72189-379-01)

Annotations

UNII (FDA Substance ID)

QTG126297Q

DICLOFENAC SODIUM

RxCUI 203214

Orange Book

A208301

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "QTG126297Q",
    "rxcui": "203214",
    "inchikey": "KPHWPUGNDIVLNH-UHFFFAOYSA-M",
    "display_name": "DICLOFENAC SODIUM",
    "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": "72189-379_4d3a653e-054e-4554-e063-6294a90a1239",
  "productndc": "72189-379",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "208301",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3%",
        "product_no": "001",
        "approval_date": "Sep 13, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DICLOFENAC SODIUM",
  "proprietary_name": "Diclofenac Sodium Gel",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA208301",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac Sodium Gel",
  "start_marketing_date": "20220908",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code M01AB55.

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