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United States · US · US:67877-772_2b2c8805-3cf1-48f8-9612-8a72a30a7f20

Diclofenac Potassium

Orange BookUNIISPLATC M01AB55

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

Identification

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

Packs · 1

  • ndc11
    6787777258
    9 PACKET in 1 CARTON (67877-772-58) / 1 POWDER, FOR SOLUTION in 1 PACKET (67877-772-49)

Annotations

UNII (FDA Substance ID)
L4D5UA6CB4
DICLOFENAC POTASSIUM
RxCUI 81997
Orange Book
A216635
AB
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": "67877-772_2b2c8805-3cf1-48f8-9612-8a72a30a7f20",
  "productndc": "67877-772",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "216635",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jul 20, 2022"
      }
    ],
    "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": "ANDA216635",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac Potassium",
  "start_marketing_date": "20221024",
  "active_numerator_strength": "50"
}

Related drugs

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