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United States · US · US:60290-088_4ff2886d-ca64-3bf4-e063-6394a90ac3ae

Diclofenac Potassium

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerUmedica Laboratories USA Inc.
CountryUS (United States)
ATC codeM01AB55
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6029008801
    30 TABLET, FILM COATED in 1 BOTTLE (60290-088-01)
  • ndc11
    6029008802
    100 TABLET, FILM COATED in 1 BOTTLE (60290-088-02)
  • ndc11
    6029008803
    500 TABLET, FILM COATED in 1 BOTTLE (60290-088-03)
  • ndc11
    6029008804
    1000 TABLET, FILM COATED in 1 BOTTLE (60290-088-04)
  • ndc11
    6029008805
    60 TABLET, FILM COATED in 1 BOTTLE (60290-088-05)

Annotations

UNII (FDA Substance ID)
L4D5UA6CB4
DICLOFENAC POTASSIUM
RxCUI 81997
Orange Book
A215750
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": "60290-088_4ff2886d-ca64-3bf4-e063-6394a90ac3ae",
  "productndc": "60290-088",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215750",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "May 11, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Jun 30, 2025"
      }
    ],
    "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": "ANDA215750",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac Potassium Tablets",
  "start_marketing_date": "20220512",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code M01AB55.

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