Back to search

United States· US:0185-0022_de0e8cdb-788a-4ebe-969d-14d44a14ddc2

Orphenadrine Citrate

A medicinal product containing orphenadrine citrate, registered in United States by Sandoz Inc.

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:0185-0022_de0e8cdb…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
ORPHENADRINE CITRATE
Manufacturer
Sandoz Inc
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
    0185002201
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0022-01)
  • ndc11
    0185-0022-01

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/f3c160f3-8e04-460f-b443-b64a316d6386
GET /v1/drugs/f3c160f3-8e04-460f-b443-b64a316d6386?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": "0185-0022",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA040327",
  "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.