United States· US:61314-637_32f12438-f75f-459e-a41f-34dcc8a9e4f7
Prednisolone Acetate
A medicinal product containing prednisolone acetate, registered in United States by Sandoz Inc.
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
- PREDNISOLONE ACETATE
- Manufacturer
- Sandoz Inc
- 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 · 6
- ndc1161314-637-05
- ndc1161314-637-10
- ndc1161314-637-15
- ndc1161314637051 BOTTLE, PLASTIC in 1 CARTON (61314-637-05) / 5 mL in 1 BOTTLE, PLASTIC
- ndc1161314637101 BOTTLE, PLASTIC in 1 CARTON (61314-637-10) / 10 mL in 1 BOTTLE, PLASTIC
- ndc1161314637151 BOTTLE, PLASTIC in 1 CARTON (61314-637-15) / 15 mL in 1 BOTTLE, PLASTIC
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Prednisolone acetate in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandPred ForteAbbVie Oy
- NetherlandsPred Forte 10 mg/ml, oogdruppels, suspensieAbbVie B.V.
- SwedenPrednisolon mibe 10 mg/ml Ögondroppar, suspensionmibe GmbH Arzneimittel
- United KingdomDeltacortril 2.5mg gastro-resistant tabletsPhoenix Labs Ltd
- GermanyDontisolon D MundheilpasteSeptodont Gmbh
- NorwayDi-Adreson-F aquosumACE Pharmaceuticals
- SwitzerlandPred Forte 1%, AugentropfensuspensionAbbVie AG
- IrelandDELTACORTRIL ENTERIC 2.5 mg gastro-resistant tabletsPhoenix Labs
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Aprednislon, Prednifluid
- Belgium · Pred Forte
- Bulgaria · Ultracortenol Eye Ointment, Кортапред
- Cyprus · Corotrope, Medopred
- Czechia · Predni-Pos, Ultracortenol
- Germany · Dontisolon D Mundheilpaste, Dontisolon D Zylinderampullen
- Denmark · Prednisolon "omet Pharma", Prednisolon Actavis
- Estonia · Prednisolon Richter, Ultracortenol
- Spain · Estilsona, Paidocort
- Finland · Pred Forte, Prednisolon .
- France · Hydrocortancyl, Prednisolone Activase
- United Kingdom (Northern Ireland) · Deltacortril, Dilacort
- Greece · Adelcort®, Cordivate
- Croatia · Ultracortenol
- Hungary · Prednisolon Richter
- Ireland · Deltacortril Enteric, Dilacort
- Iceland · Prednisolon Actavis, Prednisolon Eql Pharma
- Italy · Sintredius
- Lithuania · Prednisolon Richter, Ultarcorlene
- Luxembourg · Pred Forte
- Latvia · Prednisolon Richter, Ultarcorlene
- Malta · Corotrope, Pirver
- Netherlands · Di-Adreson-F Aquosum, Pred Forte
- Norway · Prednisolon Actavis, Prednisolon Orifarm Healthcare
- Poland · Encortolon, Pred-Ophtalene
- Portugal · Frisolona Forte, Lepicortinolo
- Romania · Ultracortenol
- Sweden · Prednisolon Actavis, Prednisolon Alternova
- Slovenia · Ultracortenol
- Slovakia · Ultracortenol
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/b0df14d4-4040-4827-af99-7025c98d8c6e GET /v1/drugs/b0df14d4-4040-4827-af99-7025c98d8c6e?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": "OPHTHALMIC",
"source": "ndc",
"strength": "10",
"substance": "PREDNISOLONE ACETATE",
"productndc": "61314-637",
"dosage_form": "SUSPENSION/ DROPS",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "NDA017469",
"marketing_category": "NDA AUTHORIZED GENERIC"
}See everything about prednisolone acetate.
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.