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United States · US · US:57896-140_969232a5-4756-2611-439e-f5092f009c62

DICLOFENAC SODIUM

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerGERI-CARE PHARMACEUTICALS CORP
CountryUS (United States)
ATC codeM01AB55
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5789614001
    1 TUBE in 1 CARTON (57896-140-01) / 100 g in 1 TUBE
  • ndc11
    5789614015
    1 TUBE in 1 CARTON (57896-140-15) / 150 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": "57896-140_969232a5-4756-2611-439e-f5092f009c62",
  "productndc": "57896-140",
  "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",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA210986",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diclofenac sodium topical gel, 1%",
  "start_marketing_date": "20211005",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code M01AB55.

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