United States· US:71321-502_9c1ede62-fd47-41f4-96da-93d65133042d

Theophylline

A theophylline product containing theophylline anhydrous, registered in United States by Brandywine Pharmaceuticals, 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:71321-502_9c1ede62…PACKS LISTED2CHECKEDJuly 26, 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
Brandywine Pharmaceuticals, 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
July 26, 2026

Packs & prices · 2

  • ndc11
    7132150210
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71321-502-10)
  • ndc11
    71321-502-10

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/f1be770c-1891-4d9f-8f8b-a0cb76a166c4
GET /v1/drugs/f1be770c-1891-4d9f-8f8b-a0cb76a166c4?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": "300",
  "substance": "THEOPHYLLINE ANHYDROUS",
  "productndc": "71321-502",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA087400",
  "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.