Ketorolac Tromethamine

In shortageOrange BookUNIISPLATC M01AB

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeM01AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0641604125
25 VIAL in 1 CARTON (0641-6041-25) / 1 mL in 1 VIAL (0641-6041-01)

Annotations

UNII (FDA Substance ID)

4EVE5946BQ

KETOROLAC TROMETHAMINE

RxCUI 28200

Orange Book

A075772

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; 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": "0641-6041_25d6c438-45d2-4162-91c2-b5caa0f86bf3",
  "productndc": "0641-6041",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "075772",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "15MG/ML",
        "product_no": "001",
        "approval_date": "Jul 21, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "30MG/ML",
        "product_no": "002",
        "approval_date": "Jul 21, 2004"
      }
    ],
    "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": "ANDA075772",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ketorolac Tromethamine",
  "start_marketing_date": "20040721",
  "active_numerator_strength": "15"
}

Related drugs

Other records sharing ATC code M01AB.

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