DICLOFENAC SODIUM

Orange BookUNIISPLATC M01AB55

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerEncube Ethicals, Inc.

CountryUS (United States)

ATC codeM01AB55

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2192203316
1 BOTTLE, PUMP in 1 CARTON (21922-033-16) / 112 g in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)

QTG126297Q

DICLOFENAC SODIUM

RxCUI 203214

Orange Book

A217646

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "QTG126297Q",
    "rxcui": "203214",
    "inchikey": "KPHWPUGNDIVLNH-UHFFFAOYSA-M",
    "display_name": "DICLOFENAC SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "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": "21922-033_28dafbef-5a91-4435-b48d-00137ea268b5",
  "productndc": "21922-033",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "217646",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2%",
        "product_no": "001",
        "approval_date": "Apr 9, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DICLOFENAC SODIUM",
  "proprietary_name": "DICLOFENAC SODIUM",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA217646",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DICLOFENAC",
  "start_marketing_date": "20250414",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code M01AB55.

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