Ketorolac Tromethamine

In shortageOrange BookUNIISPLATC M01AB

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeM01AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7133526580
3 TABLET, FILM COATED in 1 BOTTLE (71335-2658-0)
ndc11
7133526581
30 TABLET, FILM COATED in 1 BOTTLE (71335-2658-1)
ndc11
7133526582
10 TABLET, FILM COATED in 1 BOTTLE (71335-2658-2)
ndc11
7133526583
20 TABLET, FILM COATED in 1 BOTTLE (71335-2658-3)
ndc11
7133526584
90 TABLET, FILM COATED in 1 BOTTLE (71335-2658-4)
ndc11
7133526585
16 TABLET, FILM COATED in 1 BOTTLE (71335-2658-5)
ndc11
7133526586
8 TABLET, FILM COATED in 1 BOTTLE (71335-2658-6)
ndc11
7133526587
15 TABLET, FILM COATED in 1 BOTTLE (71335-2658-7)
ndc11
7133526588
5 TABLET, FILM COATED in 1 BOTTLE (71335-2658-8)
ndc11
7133526589
100 TABLET, FILM COATED in 1 BOTTLE (71335-2658-9)

Annotations

UNII (FDA Substance ID)

4EVE5946BQ

KETOROLAC TROMETHAMINE

RxCUI 28200

Orange Book

A215788

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": "71335-2658_270a9819-ffe3-435b-a02e-73878076565d",
  "productndc": "71335-2658",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215788",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Mar 23, 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": "ANDA215788",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ketorolac tromethamine",
  "start_marketing_date": "20250118",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code M01AB.

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