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United States · US · US:72684-006_d8729131-5ce6-4e9c-bbb1-1dfd5a9fca0b

KETOROLAC TROMETHAMINE

In shortageOrange BookUNIISPLATC M01AB

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

Identification

ManufacturerATNAHS PHARMA US LIMITED
CountryUS (United States)
ATC codeM01AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7268400601
    100 TABLET in 1 BOTTLE (72684-006-01)

Annotations

UNII (FDA Substance ID)
4EVE5946BQ
KETOROLAC TROMETHAMINE
RxCUI 28200
Orange Book
A216407
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": "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": "72684-006_d8729131-5ce6-4e9c-bbb1-1dfd5a9fca0b",
  "productndc": "72684-006",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216407",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Oct 21, 2022"
      }
    ],
    "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/1",
  "application_number": "ANDA216407",
  "marketing_category": "ANDA",
  "nonproprietary_name": "KETOROLAC TROMETHAMINE",
  "start_marketing_date": "20221021",
  "active_numerator_strength": "10"
}

Related drugs

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