DICLOFENAC POTASSIUM

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerLeading Pharma, LLC

CountryUS (United States)

ATC codeM01AB55

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6931550609
9 PACKET in 1 CARTON (69315-506-09) / 1 POWDER, FOR SOLUTION in 1 PACKET

Annotations

UNII (FDA Substance ID)

L4D5UA6CB4

DICLOFENAC POTASSIUM

RxCUI 81997

Orange Book

N022165

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "L4D5UA6CB4",
    "rxcui": "81997",
    "inchikey": "KXZOIWWTXOCYKR-UHFFFAOYSA-M",
    "display_name": "DICLOFENAC POTASSIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "69315-506_9c24af27-0a21-4fb7-a8fb-55c92373b852",
  "productndc": "69315-506",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "022165",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jun 17, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DICLOFENAC POTASSIUM",
  "proprietary_name": "DICLOFENAC POTASSIUM",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022165",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "DICLOFENAC POTASSIUM",
  "start_marketing_date": "20221220",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code M01AB55.

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