Back to search
🇺🇸

United States · US · US:28595-031_47d0b2fe-e786-c7a7-e063-6394a90a3b3a

Orudis

Orange BookUNIISPLATC M01AE53

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

Identification

ManufacturerAllegis Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeM01AE53
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2859503160
    60 CAPSULE in 1 BOTTLE (28595-031-60)

Annotations

UNII (FDA Substance ID)
90Y4QC304K
KETOPROFEN
RxCUI 6142
Orange Book
A074014
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "90Y4QC304K",
    "rxcui": "6142",
    "inchikey": "DKYWVDODHFEZIM-UHFFFAOYSA-N",
    "display_name": "KETOPROFEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "47d0b808-7142-c7a9-e063-6394a90a6e0d": {
      "match": "brand_token",
      "title": "ORUDIS (KETOPROFEN) CAPSULE [ALLEGIS PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-01-12"
    }
  },
  "productid": "28595-031_47d0b2fe-e786-c7a7-e063-6394a90a3b3a",
  "productndc": "28595-031",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "074014",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jan 29, 1993"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Jan 29, 1993"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "75MG",
        "product_no": "003",
        "approval_date": "Jan 29, 1993"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "KETOPROFEN",
  "proprietary_name": "Orudis",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA074014",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ketoprofen",
  "start_marketing_date": "20260107",
  "active_numerator_strength": "75"
}

Related drugs

Other records sharing ATC code M01AE53.

Access this data programmatically

Query Orudis 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.