United States· US:0054-0084_d97e7e61-defc-47f5-aeca-11cecae47e79
Zaleplon
A zaleplon product containing zaleplon, registered in United States by Hikma Pharmaceuticals USA Inc.. The same ATC class is registered in 5 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Zaleplon is registered in 5 of 19 countries.
Countries holding a registration under ATC N05CF03 (zaleplon), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 4 of them publish a price we can compare per daily dose
Zaleplon · ATC N05CF03
5 / 19 countries
- Belgiumprice
- Finlandprice
- Polandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ZALEPLON
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Country
- United States (US)
- ATC code
- N05CF03
- ATC class
- Zaleplon
- Defined daily dose
- 10 mg, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc110054008425100 CAPSULE in 1 BOTTLE (0054-0084-25)
- ndc110054-0084-25
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
176 interactions on record for zaleplon.
Graded by severity as the source publishes them — 4 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Zaleplon · interactions on record
176 records
- 4 severe
- 72 moderate
- 7 minor
- 83 info
Most severe, free to view
- MorphineN02AA01severe
- MorphinN07BC09severe
- HydrocodoneR05DA03severe
- CodeineR05DA04severe
10 more interactions with mechanism and management, from a commercially licensed source.
Sign in to check- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Zaleplon in 4 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomSonata 5mg capsulesSigma Pharmaceuticals Plc
- FinlandSonataMEDA AB
- BelgiumSonata 5 mgMeda
- PolandMorfeoAdamed Pharma S.A.
Authorised across Europe · EMA
The same active substance is authorised in 1 EEA country. Names it is sold under:
- Poland · Morfeo
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/fe9fcc66-54ec-4df8-a902-3ef3822bb790 GET /v1/drugs/fe9fcc66-54ec-4df8-a902-3ef3822bb790?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": "ORAL",
"source": "ndc",
"strength": "5",
"substance": "ZALEPLON",
"productndc": "0054-0084",
"dosage_form": "CAPSULE",
"dea_schedule": "CIV",
"strength_unit": "mg/1",
"application_number": "ANDA077237",
"marketing_category": "ANDA"
}See everything about zaleplon.
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.