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United States · US · US:70518-4255_5218ed32-de80-3ee6-e063-6394a90a7821

ketorolac tromethamine

In shortageOrange BookUNIISPLATC M01AB

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

Identification

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

Packs · 2

  • ndc11
    7051842550
    20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4255-0)
  • ndc11
    7051842551
    12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4255-1)

Annotations

UNII (FDA Substance ID)
4EVE5946BQ
KETOROLAC TROMETHAMINE
RxCUI 28200
Orange Book
A217038
AB
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": "70518-4255_5218ed32-de80-3ee6-e063-6394a90a7821",
  "productndc": "70518-4255",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "217038",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "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": "ANDA217038",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ketorolac tromethamine",
  "start_marketing_date": "20250115",
  "active_numerator_strength": "10"
}

Related drugs

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