United States· US:69344-144_6ec8c9cf-7780-4bb1-8233-8a4e28ab43f0
Sprix
A medicinal product containing ketorolac tromethamine, registered in United States by Zyla Life Sciences US LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- KETOROLAC TROMETHAMINE
- Manufacturer
- Zyla Life Sciences US LLC
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc1169344-144-43
- ndc1169344-144-53
- ndc1169344144435 CARTON in 1 CARTON (69344-144-43) / 1 BOTTLE, SPRAY in 1 CARTON (69344-144-53) / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63)
- ndc1169344144531 BOTTLE, SPRAY in 1 CARTON (69344-144-53) / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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.
- United KingdomAcular 0.5% eye dropsDowelhurst Ltd
- CanadaACULARABBVIE CORPORATION
- ItalyBENKETOLPHARMABER S.R.L.
- CzechiaKETOROLAC TROMETAMOL BROWN & BURKBrown & Burk IR Limited, Dublin
- SpainACULAR 5 mg/ml COLIRIO EN SOLUCIONAbbvie Spain, S.L.U.
- SwedenCaloket 30 mg/ml Injektions-/infusionsvätska, lösningEQL Pharma AB
- FinlandAcularAllergan Pharmaceuticals Ireland
- NorwayCaloketEQL Pharma AB
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/51c1b373-c7ae-4a94-9acc-dc5008087f9b GET /v1/drugs/51c1b373-c7ae-4a94-9acc-dc5008087f9b?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.
{
"route": "NASAL",
"source": "ndc",
"strength": "15.75",
"substance": "KETOROLAC TROMETHAMINE",
"productndc": "69344-144",
"dosage_form": "SPRAY, METERED",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA022382",
"marketing_category": "NDA"
}See everything about ketorolac tromethamine.
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.