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United States · US · US:70512-750_47d44b29-dfd3-eace-e063-6394a90a4d24

Diclofenac Potassium

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerSOLA Pharmaceuticals, LLC
CountryUS (United States)
ATC codeM01AB55
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7051275010
    100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70512-750-10)
  • ndc11
    7051275050
    500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70512-750-50)

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": "70512-750_47d44b29-dfd3-eace-e063-6394a90a4d24",
  "productndc": "70512-750",
  "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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