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United States · US · US:82804-010_94586867-c75b-4d60-be1d-03a9e4b7cd10

Diclofenac Potassium

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeM01AB55
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8280401030
    30 TABLET, COATED in 1 BOTTLE (82804-010-30)
  • ndc11
    8280401060
    60 TABLET, COATED in 1 BOTTLE (82804-010-60)
  • ndc11
    8280401090
    90 TABLET, COATED in 1 BOTTLE (82804-010-90)

Annotations

UNII (FDA Substance ID)
L4D5UA6CB4
DICLOFENAC POTASSIUM
RxCUI 81997
Orange Book
A075229
ABAB
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": "82804-010_94586867-c75b-4d60-be1d-03a9e4b7cd10",
  "productndc": "82804-010",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "075229",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Nov 20, 1998"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Sep 16, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DICLOFENAC POTASSIUM",
  "proprietary_name": "Diclofenac Potassium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075229",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diclofenac potassium",
  "start_marketing_date": "20201219",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code M01AB55.

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