United States· US:68999-556_43905546-0c51-ab49-e063-6294a90a4a31

Theophylline

A theophylline product containing theophylline anhydrous, registered in United States by Chartwell Governmental & Specialty RX, LLC.. The same ATC class is registered in 12 of our 19 countries.

ATC R03DA04US 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…normalisedTheophyllineATCR03DA04REGISTER NO.US:68999-556_43905546…PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

Theophylline is registered in 12 of 19 countries.

Countries holding a registration under ATC R03DA04 (theophylline), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 6 of them publish a price we can compare per daily dose

Theophylline · ATC R03DA04

12 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Germany
  • Ireland
  • Japan
  • Norwayprice
  • 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.

Price per daily dose

What a daily dose of theophylline costs, country by country.

Normalised to the WHO defined daily dose (0.4 g), so markets compare like for like.

  • United States: $0.71 per daily dose (median across products in the class)
  • Public list prices, converted to USD at the rate date shown

Theophylline · price per daily dose (0.4 g)

USD · FX 28 Sept 2026

  • US United States$0.71 (acquisition cost)
Median listed price per WHO defined daily dose, in each market that publishes a price. US = pharmacy acquisition cost (CMS NADAC), not a retail price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
THEOPHYLLINE ANHYDROUS
Manufacturer
Chartwell Governmental & Specialty RX, LLC.
Country
United States (US)
ATC code
R03DA04
ATC class
Theophylline
Defined daily dose
0.4 g, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    68999-556-24
  • ndc11
    6899955624
    2 TRAY in 1 BOX (68999-556-24) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (68999-556-51)

Regulatory notes

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

Interactions

438 interactions on record for theophylline.

Graded by severity as the source publishes them — 34 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

Theophylline · interactions on record

438 records

  • 34 severe
  • 222 moderate
  • 45 minor
  • 132 info

Most severe, free to view

  • MexiletineC01BB02severe
  • RiociguatC02KX05severe
  • PindololC07AA03severe
  • PropranololC07AA05severe

5 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

Theophylline in 13 other countries

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

All theophylline products

Authorised across Europe · EMA

The same active substance is authorised in 26 EEA countries. Names it is sold under:

  • Austria · Theospirex, Theospirex Retard
  • Belgium · Xanthium
  • Bulgaria · Теотард
  • Cyprus · Theo-Dur
  • Czechia · Euphyllin Cr N
  • Germany · Afpred Forte-Theo, Bronchoretard
  • Denmark · Theo-Dur, Unixan
  • Estonia · Teotard
  • Spain · Elixifilin, Teromol Retard
  • Finland · Retafyllin
  • France · Dilatrane, Tedralan
  • United Kingdom (Northern Ireland) · Uniphyllin
  • Greece · Theo-Bros, Theo-Dur
  • Croatia · Teotard
  • Hungary · Theophyllini Fono Vii. Naturland, Theophyllini Fono Viii. Parma
  • Ireland · Uniphyllin
  • Lithuania · Teotard
  • Luxembourg · Xanthium
  • Latvia · Teotard
  • Norway · Theo-Dur
  • Poland · Euphyllin Long, Theophyllinum Tramco
  • Portugal · Unicontin
  • Romania · Teotard
  • Sweden · Theo-Dur
  • Slovenia · Teotard
  • Slovakia · Euphyllin Cr N 200, Euphyllin Cr N 300

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/d2804923-a193-41b7-8c5f-bc2e2aa2b0de
GET /v1/drugs/d2804923-a193-41b7-8c5f-bc2e2aa2b0de?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": "80",
  "substance": "THEOPHYLLINE ANHYDROUS",
  "productndc": "68999-556",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/15mL",
  "application_number": "ANDA091156",
  "marketing_category": "ANDA"
}

See everything about theophylline.

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.