Ketorolac Tromethamine

In shortageOrange BookUNIISPLATC M01AB

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeM01AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
6318712810
10 TABLET, FILM COATED in 1 BOTTLE (63187-128-10)
ndc11
6318712812
12 TABLET, FILM COATED in 1 BOTTLE (63187-128-12)
ndc11
6318712815
15 TABLET, FILM COATED in 1 BOTTLE (63187-128-15)
ndc11
6318712820
20 TABLET, FILM COATED in 1 BOTTLE (63187-128-20)
ndc11
6318712830
30 TABLET, FILM COATED in 1 BOTTLE (63187-128-30)
ndc11
6318712860
60 TABLET, FILM COATED in 1 BOTTLE (63187-128-60)
ndc11
6318712890
90 TABLET, FILM COATED in 1 BOTTLE (63187-128-90)

Annotations

UNII (FDA Substance ID)

4EVE5946BQ

KETOROLAC TROMETHAMINE

RxCUI 28200

Orange Book

A074754

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": "63187-128_dd66f622-8f11-4a86-a70c-9a9a8300fda5",
  "productndc": "63187-128",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "074754",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "May 16, 1997"
      }
    ],
    "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": "ANDA074754",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ketorolac Tromethamine",
  "start_marketing_date": "19980617",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code M01AB.

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