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United States · US · US:75834-338_46982e49-ee38-ad56-e063-6394a90a2816

DICLOFENAC POTASSIUM

Orange BookUNIISPLATC M01AB55

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

Identification

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

Packs · 2

  • ndc11
    7583433801
    1 POWDER, FOR SOLUTION in 1 PACKET (75834-338-01)
  • ndc11
    7583433802
    9 POWDER, FOR SOLUTION in 1 CARTON (75834-338-02)

Annotations

UNII (FDA Substance ID)
L4D5UA6CB4
DICLOFENAC POTASSIUM
RxCUI 81997
Orange Book
A217010
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": "75834-338_46982e49-ee38-ad56-e063-6394a90a2816",
  "productndc": "75834-338",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "217010",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Aug 29, 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": "ANDA217010",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diclofenac potassium",
  "start_marketing_date": "20251215",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code M01AB55.

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