United States· US:65862-215_36ab371f-c2fe-4c1d-ad60-801b8f118f4e

ZALEPLON

A zaleplon product containing zaleplon, registered in United States by Aurobindo Pharma Limited. The same ATC class is registered in 5 of our 19 countries.

ATC N05CF03US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedZALEPLONATCN05CF03REGISTER NO.US:65862-215_36ab371f…PACKS LISTED4CHECKEDSeptember 27, 2026

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
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
ZALEPLON
Manufacturer
Aurobindo Pharma Limited
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 · 4

  • ndc11
    65862-215-01
  • ndc11
    65862-215-05
  • ndc11
    6586221501
    100 CAPSULE in 1 BOTTLE (65862-215-01)
  • ndc11
    6586221505
    500 CAPSULE in 1 BOTTLE (65862-215-05)

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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

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.

All zaleplon products

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/e4d50007-12ff-4f59-bb6a-f686afbd258a
GET /v1/drugs/e4d50007-12ff-4f59-bb6a-f686afbd258a?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": "10",
  "substance": "ZALEPLON",
  "productndc": "65862-215",
  "dosage_form": "CAPSULE",
  "dea_schedule": "CIV",
  "strength_unit": "mg/1",
  "application_number": "ANDA078829",
  "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.