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United States · US · US:71337-046_2a1e049f-58f9-40e8-b7a6-bcd19ef51f75

DICLOFENAC POTASSIUM

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerHavix Group Inc d-b-a Aavis Pharmaceuticals
CountryUS (United States)
ATC codeM01AB55
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7133704601
    100 TABLET in 1 BOTTLE (71337-046-01)
  • ndc11
    7133704605
    500 TABLET in 1 BOTTLE (71337-046-05)

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": "71337-046_2a1e049f-58f9-40e8-b7a6-bcd19ef51f75",
  "productndc": "71337-046",
  "dosage_form": "TABLET",
  "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, film coated",
  "start_marketing_date": "20230625",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code M01AB55.

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