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United States · US · US:0363-7065_867bef8c-ad27-7567-cfe7-fc27e8cddd4d

Diclofenac Sodium Topical Gel 1%

Orange BookUNIISPLATC M01AB55

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

Identification

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

Packs · 4

  • ndc11
    0363706510
    1 TUBE in 1 CARTON (0363-7065-10) / 100 g in 1 TUBE
  • ndc11
    0363706515
    1 TUBE in 1 CARTON (0363-7065-15) / 150 g in 1 TUBE
  • ndc11
    0363706520
    2 TUBE in 1 CARTON (0363-7065-20) / 100 g in 1 TUBE
  • ndc11
    0363706550
    1 TUBE in 1 CARTON (0363-7065-50) / 50 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
QTG126297Q
DICLOFENAC SODIUM
RxCUI 203214
Orange Book
A210986
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": "0363-7065_867bef8c-ad27-7567-cfe7-fc27e8cddd4d",
  "productndc": "0363-7065",
  "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": "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": "20200914",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code M01AB55.

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