Ketorolac Tromethamine

In shortageOrange BookUNIISPLATC M01AB

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

Identification

ManufacturerDirect_rx

CountryUS (United States)

ATC codeM01AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7218958301
1 mL in 1 CARTON (72189-583-01)

Annotations

UNII (FDA Substance ID)

4EVE5946BQ

KETOROLAC TROMETHAMINE

RxCUI 28200

Orange Book

A204216

APAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Ketorolac Tromethamine Injection

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",
  "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": "72189-583_4d3aadb1-8a83-d5ab-e063-6394a90a0267",
  "productndc": "72189-583",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "204216",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "15MG/ML",
        "product_no": "001",
        "approval_date": "Nov 1, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "30MG/ML",
        "product_no": "002",
        "approval_date": "Nov 1, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "KETOROLAC TROMETHAMINE",
  "shortage_reason": "Ketorolac Tromethamine Injection",
  "shortage_status": "current",
  "proprietary_name": "Ketorolac Tromethamine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA204216",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ketorolac Tromethamine",
  "start_marketing_date": "20240924",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code M01AB.

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