Crcle Diclofenac Sodium Topical Gel 1%

Orange BookUNIIATC M01AB55

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

Identification

ManufacturerInnovus Pharmaceuticals Inc.

CountryUS (United States)

ATC codeM01AB55

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5748359601
1 TUBE in 1 CARTON (57483-596-01) / 150 g in 1 TUBE

Annotations

UNII (FDA Substance ID)

QTG126297Q

DICLOFENAC SODIUM

RxCUI 203214

Orange Book

A210986

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",
  "productid": "57483-596_59143e11-f5ea-462d-a283-929ece6ba550",
  "productndc": "57483-596",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "210986",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Jan 27, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DICLOFENAC SODIUM",
  "proprietary_name": "Crcle Diclofenac Sodium Topical Gel 1%",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA210986",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac Sodium Topical Gel 1%",
  "start_marketing_date": "20220110",
  "active_numerator_strength": "10"
}

Related drugs

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