Back to search

United States· US:49999-046_018c5bb2-b5ea-4e62-8670-3e099c32ead9

Orphenadrine Citrate

A medicinal product containing orphenadrine citrate, registered in United States by Lake Erie Medical DBA Quality Care Products LLC.

US 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…normalisedOrphenadrine CitrateATC—REGISTER NO.US:49999-046_018c5bb2…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ORPHENADRINE CITRATE
Manufacturer
Lake Erie Medical DBA Quality Care Products LLC
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 · 2

  • ndc11
    49999-046-60
  • ndc11
    4999904660
    60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49999-046-60)

Regulatory notes

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

Same medicine, other countries

Orphenadrine citrate in 7 other countries

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

All orphenadrine citrate products

Authorised across Europe · EMA

The same active substance is authorised in 7 EEA countries. Names it is sold under:

  • Germany · Norflex, Norflex N
  • Denmark · Lysantin
  • Finland · Norflex
  • United Kingdom (Northern Ireland) · Orphenadrine Hydrochloride Rosemont Pharmaceuticals
  • Greece · Orphedrin
  • Italy · Disipal
  • Sweden · Norflex

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/25254e14-2694-45fa-ac45-5664ce21a03e
GET /v1/drugs/25254e14-2694-45fa-ac45-5664ce21a03e?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": "100",
  "substance": "ORPHENADRINE CITRATE",
  "productndc": "49999-046",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA040284",
  "marketing_category": "ANDA"
}

See everything about orphenadrine citrate.

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.