Ketorolac Tromethamine

In shortageOrange BookUNIISPLATC M01AB

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeM01AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332316116
25 VIAL, SINGLE-USE in 1 TRAY (63323-161-16) / 1 mL in 1 VIAL, SINGLE-USE (63323-161-41)

Annotations

UNII (FDA Substance ID)

4EVE5946BQ

KETOROLAC TROMETHAMINE

RxCUI 28200

Orange Book

A075784

APAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Ketorolac Tromethamine Tablet

Raw payload (JSON)

{
  "unii": {
    "unii": "4EVE5946BQ",
    "rxcui": "28200",
    "inchikey": "BWHLPLXXIDYSNW-UHFFFAOYSA-N",
    "display_name": "KETOROLAC TROMETHAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "521b3d09-df08-fcae-e063-6294a90a6545": {
      "match": "brand_token",
      "title": "KETOROLAC TROMETHAMINE TABLET, FILM COATED [INJECTA MEDCIAL LLC]",
      "spl_version": "3",
      "published_date": "2026-05-28"
    }
  },
  "productid": "63323-161_2b1c6066-d9e0-40a0-ade5-776fc35a3626",
  "productndc": "63323-161",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "075784",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "15MG/ML",
        "product_no": "001",
        "approval_date": "Jan 11, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "30MG/ML",
        "product_no": "002",
        "approval_date": "Jan 11, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "KETOROLAC TROMETHAMINE",
  "shortage_reason": "Ketorolac Tromethamine Tablet",
  "shortage_status": "current",
  "proprietary_name": "Ketorolac Tromethamine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA075784",
  "marketing_category": "ANDA",
  "nonproprietary_name": "KETOROLAC TROMETHAMINE",
  "start_marketing_date": "20010905",
  "active_numerator_strength": "15"
}

Related drugs

Other records sharing ATC code M01AB.

Access this data programmatically

Query Ketorolac Tromethamine 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