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United States · US · US:72189-555_4c4aad0a-641f-1aa7-e063-6294a90a13da

Ketorolac Tromethamine

In shortageOrange BookUNIISPLATC M01AB

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

Identification

ManufacturerDirect_Rx
CountryUS (United States)
ATC codeM01AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7218955510
    10 TABLET, FILM COATED in 1 BOTTLE (72189-555-10)
  • ndc11
    7218955515
    15 TABLET, FILM COATED in 1 BOTTLE (72189-555-15)
  • ndc11
    7218955520
    20 TABLET, FILM COATED in 1 BOTTLE (72189-555-20)
  • ndc11
    7218955530
    30 TABLET, FILM COATED in 1 BOTTLE (72189-555-30)

Annotations

UNII (FDA Substance ID)
4EVE5946BQ
KETOROLAC TROMETHAMINE
RxCUI 28200
Orange Book
A216759
AB
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": "ORAL",
  "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": "72189-555_4c4aad0a-641f-1aa7-e063-6294a90a13da",
  "productndc": "72189-555",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "216759",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Feb 23, 2023"
      }
    ],
    "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/1",
  "application_number": "ANDA216759",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ketorolac Tromethamine",
  "start_marketing_date": "20240603",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code M01AB.

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