United States· US:70518-3800_346893b1-a151-71ad-e063-6394a90ac2da

ketorolac tromethamine

A acetic acid derivatives and related substances product containing ketorolac tromethamine, registered in United States by REMEDYREPACK INC.. The same ATC class is registered in 2 of our 19 countries.

In shortageATC M01ABOrange BookUS label

Checked against FDA National Drug Code directory (United States) on September 12, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about ketorolac tromethamineAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

Where it is registered

Ketorolac tromethamine is registered in 2 of 19 countries.

Countries holding a registration under ATC M01AB (acetic acid derivatives and related substances), each read from that country’s own register.

This record: United States, from FDA National Drug Code directory (United States)
2 of them publish a price we can compare per daily dose

Search ketorolac tromethamine products by name

Ketorolac tromethamine · ATC M01AB

2 / 19 countries

Polandprice
United Statesprice

Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)

Active substance: ketorolac tromethamine
Manufacturer: REMEDYREPACK INC.
Country: United States (US)
ATC code: M01AB
ATC class: Acetic acid derivatives and related substances
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: September 12, 2026

Packs & prices · 1

ndc11
7051838000
25 VIAL in 1 CARTON (70518-3800-0) / 2 mL in 1 VIAL (70518-3800-1)

Regulatory notes

UNII (FDA substance ID)

4EVE5946BQ

KETOROLAC TROMETHAMINE

RxCUI 28200

Orange Book

A204216

APAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Ketorolac Tromethamine Injection

Same medicine, other countries

Ketorolac tromethamine in 14 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All ketorolac tromethamine products

Authorised across Europe · EMA

The same active substance is authorised in 24 EEA countries. Names it is sold under:

Austria · Acular, Ketorolac Micro Labs
Belgium · Aculare, Taradyl
Bulgaria · Кетоажур, Кеторолак Вижън
Cyprus · Errkes
Czechia · Ketorolac Trometamol Brown & Burk
Germany · Ketorolac Micro Labs, Ketovision
Denmark · Acular, Caloket
Estonia · Ketorolac Baxter
Spain · Acular, Ketorolaco Kabi
Finland · Caloket, Ketorolac S.A.L.F.
France · Acular
United Kingdom (Northern Ireland) · Acular, Ketorolac Trometamol Baxter Healthcare
Greece · Acular, Errkes
Ireland · Acular
Iceland · Toradol
Italy · Acular, Benketol
Lithuania · Ketanov, Ketorolac Baxter
Luxembourg · Aculare, Taradyl
Latvia · Ketanov, Ketorolac Baxter
Norway · Caloket, Ketorolac Trometamol S.A.L.F.
Poland · Ketorolac Trometamol Brown & Burk
Portugal · Acular, Cetorolac
Romania · Ketanov, Ketorol
Sweden · Caloket, Ketorolac S.A.L.F.

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload

GET /v1/drugs/db44355b-d36e-4961-87df-85be30c8a8be
GET /v1/drugs/db44355b-d36e-4961-87df-85be30c8a8be?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "4EVE5946BQ",
    "rxcui": "28200",
    "inchikey": "BWHLPLXXIDYSNW-UHFFFAOYSA-N",
    "display_name": "KETOROLAC TROMETHAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 4
  },
  "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": "70518-3800_346893b1-a151-71ad-e063-6394a90ac2da",
  "productndc": "70518-3800",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "204216",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "15MG/ML",
        "product_no": "001",
        "approval_date": "Nov 1, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "30MG/ML",
        "product_no": "002",
        "approval_date": "Nov 1, 2016"
      }
    ],
    "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/mL",
  "application_number": "ANDA204216",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ketorolac tromethamine",
  "start_marketing_date": "20230719",
  "active_numerator_strength": "30"
}

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This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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