Ketorolac Tromethamine

In shortageOrange BookUNIISPLATC M01AB

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

Identification

ManufacturerCardinal Health 107, LLC

CountryUS (United States)

ATC codeM01AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5515493685
5 VIAL, SINGLE-DOSE in 1 BAG (55154-9368-5) / 1 mL in 1 VIAL, SINGLE-DOSE

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 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": "55154-9368_b7d8d737-2f9b-45dd-aaee-8d8bc882baf2",
  "productndc": "55154-9368",
  "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 Injection",
  "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": "20001018",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code M01AB.

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