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United States · US · US:73469-2053_3f399f7d-a801-4fce-9c3a-7e3a4d6e2507

Diclofenac sodium

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerScholl's Wellness Company
CountryUS (United States)
ATC codeM01AB55
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7346920531
    1 TUBE in 1 CARTON (73469-2053-1) / 100 g in 1 TUBE
  • ndc11
    7346920538
    1 TUBE in 1 CARTON (73469-2053-8) / 50 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A208077
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": "73469-2053_3f399f7d-a801-4fce-9c3a-7e3a4d6e2507",
  "productndc": "73469-2053",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "208077",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Mar 18, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DICLOFENAC SODIUM",
  "proprietary_name": "Diclofenac sodium",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA208077",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac",
  "start_marketing_date": "20201030",
  "active_numerator_strength": "10"
}

Related drugs

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