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United States· US:72789-457_48d8a76e-8103-9485-e063-6294a90af9ab

CEVIMELINE HYDROCHLORIDE

A cevimeline product containing cevimeline hydrochloride, registered in United States by PD-Rx Pharmaceuticals, Inc.. The same ATC class is registered in 3 of our 19 countries.

ATC N07AX03US 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…normalisedCEVIMELINE HYDROCHLORIDEATCN07AX03REGISTER NO.US:72789-457_48d8a76e…PACKS LISTED4CHECKEDAugust 23, 2026

Where it is registered

Cevimeline is registered in 3 of 19 countries.

Countries holding a registration under ATC N07AX03 (cevimeline), 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

Cevimeline · ATC N07AX03

3 / 19 countries

  • Japan
  • Norwayprice
  • 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
CEVIMELINE HYDROCHLORIDE
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Country
United States (US)
ATC code
N07AX03
ATC class
Cevimeline
Defined daily dose
90 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
August 23, 2026

Packs & prices · 4

  • ndc11
    72789-457-01
  • ndc11
    72789-457-30
  • ndc11
    7278945701
    100 CAPSULE in 1 BOTTLE, PLASTIC (72789-457-01)
  • ndc11
    7278945730
    30 CAPSULE in 1 BOTTLE, PLASTIC (72789-457-30)

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

144 interactions on record for cevimeline.

Graded by severity as the source publishes them — 2 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

Cevimeline · interactions on record

144 records

  • 2 severe
  • 119 moderate
  • 23 minor

Most severe, free to view

  • SiponimodL04AA42severe
  • SiponimodL04AE03severe
  • ClotrimazoleA01AB18moderate
  • CimetidineA02BA01moderate
  • 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

Cevimeline in 1 other country

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

All cevimeline products

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/e0c6355f-cb55-4eb3-b52f-b5fd08914ae4
GET /v1/drugs/e0c6355f-cb55-4eb3-b52f-b5fd08914ae4?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": "30",
  "substance": "CEVIMELINE HYDROCHLORIDE",
  "productndc": "72789-457",
  "dosage_form": "CAPSULE",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA216682",
  "marketing_category": "ANDA"
}

See everything about cevimeline.

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.