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United States· US:70792-102_aadca804-560a-4262-843d-2cb4e2fbe851

TONMYA

A cyclobenzaprine product containing cyclobenzaprine hydrochloride, registered in United States by Tonix Medicines, Inc.. The same ATC class is registered in 3 of our 19 countries.

ATC M03BX08Orange BookUS 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…normalisedTONMYAATCM03BX08REGISTER NO.US:70792-102_aadca804…PACKS LISTED4CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about cyclobenzaprine hydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Cyclobenzaprine is registered in 3 of 19 countries.

Countries holding a registration under ATC M03BX08 (cyclobenzaprine), 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
Search cyclobenzaprine products by name

Cyclobenzaprine · ATC M03BX08

3 / 19 countries

  • Canada
  • 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
Cyclobenzaprine Hydrochloride
Manufacturer
Tonix Medicines, Inc.
Country
United States (US)
ATC code
M03BX08
ATC class
Cyclobenzaprine
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 4

  • ndc11
    7079210214
    14 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-14)
  • ndc11
    7079210230
    30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-30)
  • ndc11
    7079210260
    60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-60)
  • ndc11
    7079210290
    90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70792-102-90)

Regulatory notes

UNII (FDA substance ID)
0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDE
RxCUI 52101
Orange Book
N219428
DailyMed SPL labels
1 version tracked

Interactions

319 interactions on record for cyclobenzaprine.

Graded by severity as the source publishes them — 20 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
Check cyclobenzaprine against other medicinesHow interaction checks work

Cyclobenzaprine · interactions on record

319 records

  • 20 severe
  • 113 moderate
  • 1 minor
  • 185 info

Most severe, free to view

  • FenfluramineA08AA02severe
  • DexfenfluramineA08AA04severe
  • Potassium chlorideA12BA01severe
  • Potassium citrateA12BA02severe
  • 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

Cyclobenzaprine in 3 other countries

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

All cyclobenzaprine products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Spain · Yurelax
  • Italy · Flexiban
  • Portugal · Flexiban, Miodia

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/84505b59-6d0f-4dbd-98ad-9ff4f43d5637
GET /v1/drugs/84505b59-6d0f-4dbd-98ad-9ff4f43d5637?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.

{
  "unii": {
    "unii": "0VE05JYS2P",
    "rxcui": "52101",
    "inchikey": "VXEAYBOGHINOKW-UHFFFAOYSA-N",
    "display_name": "CYCLOBENZAPRINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBLINGUAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "6fa59588-ce9b-48cf-8c5f-725a448f8571": {
      "match": "brand_token",
      "title": "TONMYA (CYCLOBENZAPRINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [TONIX MEDICINES, INC.]",
      "spl_version": "3",
      "published_date": "2025-11-17"
    }
  },
  "productid": "70792-102_aadca804-560a-4262-843d-2cb4e2fbe851",
  "productndc": "70792-102",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "219428",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2.8MG",
        "product_no": "001",
        "approval_date": "Aug 15, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOBENZAPRINE HYDROCHLORIDE",
  "proprietary_name": "TONMYA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA219428",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cyclobenzaprine Hydrochloride",
  "start_marketing_date": "20250815",
  "active_numerator_strength": "2.8"
}
API referenceMCP serverPlans

See everything about cyclobenzaprine.

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.

Try it freeOpen in the console