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United States · US · US:80425-0457_295d5e97-b95f-d7d1-e063-6394a90af14f

Diclofenac Potassium

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC codeM01AB55
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8042504571
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0457-1)
  • ndc11
    8042504572
    60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0457-2)
  • ndc11
    8042504573
    90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0457-3)

Annotations

UNII (FDA Substance ID)
L4D5UA6CB4
DICLOFENAC POTASSIUM
RxCUI 81997
Orange Book
A215787
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": "80425-0457_295d5e97-b95f-d7d1-e063-6394a90af14f",
  "productndc": "80425-0457",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215787",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Mar 15, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Nov 9, 2023"
      }
    ],
    "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": "ANDA215787",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diclofenac potassium",
  "start_marketing_date": "20241021",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code M01AB55.

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