Ketorolac Tromethamine

In shortageOrange BookUNIISPLATC M01AB

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeM01AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7642003201
100 TABLET, FILM COATED in 1 BOTTLE (76420-032-01)
ndc11
7642003202
2 TABLET, FILM COATED in 1 BOTTLE (76420-032-02)
ndc11
7642003204
4 TABLET, FILM COATED in 1 BOTTLE (76420-032-04)
ndc11
7642003207
7 TABLET, FILM COATED in 1 BOTTLE (76420-032-07)
ndc11
7642003210
10 TABLET, FILM COATED in 1 BOTTLE (76420-032-10)
ndc11
7642003215
15 TABLET, FILM COATED in 1 BOTTLE (76420-032-15)
ndc11
7642003220
20 TABLET, FILM COATED in 1 BOTTLE (76420-032-20)
ndc11
7642003230
30 TABLET, FILM COATED in 1 BOTTLE (76420-032-30)
ndc11
7642003260
60 TABLET, FILM COATED in 1 BOTTLE (76420-032-60)
ndc11
7642003290
90 TABLET, FILM COATED in 1 BOTTLE (76420-032-90)

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 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": "76420-032_04ab174a-3ae9-2b8e-e063-6394a90a1df5",
  "productndc": "76420-032",
  "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 Injection",
  "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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