Diclofenac sodium

Orange BookUNIISPLATC M01AB55

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

Identification

ManufacturerIngenus Pharmaceuticals, LLC

CountryUS (United States)

ATC codeM01AB55

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5074227801
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-278-01)

Annotations

UNII (FDA Substance ID)

QTG126297Q

DICLOFENAC SODIUM

RxCUI 203214

Orange Book

A216275

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": "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": "50742-278_37537219-52df-4924-8bae-4188c8eb922b",
  "productndc": "50742-278",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216275",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Sep 23, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DICLOFENAC SODIUM",
  "proprietary_name": "Diclofenac sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216275",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diclofenac sodium",
  "start_marketing_date": "20220926",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code M01AB55.

Access this data programmatically

Query Diclofenac sodium and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs