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United States· US:23155-726_50a37968-605e-481b-af03-db963542a6c6

Labetalol Hydrochloride

A labetalol product containing labetalol hydrochloride, registered in United States by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.. The same ATC class is registered in 16 of our 19 countries.

ATC C07AG01US 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…normalisedLabetalol HydrochlorideATCC07AG01REGISTER NO.US:23155-726_50a37968…PACKS LISTED4CHECKEDSeptember 27, 2026

Where it is registered

Labetalol is registered in 16 of 19 countries.

Countries holding a registration under ATC C07AG01 (labetalol), each read from that country’s own register.

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

Labetalol · ATC C07AG01

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Spainprice
  • Sweden
  • Switzerlandprice
  • 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 labetalol costs, country by country.

Normalised to the WHO defined daily dose (0.6 g), the median price runs from $0.43 in United States to $1.65 in Switzerland — a ×3.8 gap.

  • United States: $0.43 per daily dose (median across products in the class)
  • Public list prices, converted to USD at the rate date shown
  • US figures are pharmacy acquisition cost (CMS NADAC), not retail

Labetalol · price per daily dose (0.6 g)

USD · FX 28 Sept 2026

  • CH Switzerland$1.65
  • ES Spain$0.96
  • FR France$0.57
  • US United States$0.43 (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
LABETALOL HYDROCHLORIDE
Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Country
United States (US)
ATC code
C07AG01
ATC class
Labetalol
Defined daily dose
0.6 g, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 4

  • ndc11
    2315572601
    100 TABLET in 1 BOTTLE (23155-726-01)
  • ndc11
    2315572605
    500 TABLET in 1 BOTTLE (23155-726-05)
  • ndc11
    23155-726-01
  • ndc11
    23155-726-05

Regulatory notes

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

Interactions

316 interactions on record for labetalol.

Graded by severity as the source publishes them — 35 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

Labetalol · interactions on record

316 records

  • 35 severe
  • 190 moderate
  • 23 minor
  • 63 info

Most severe, free to view

  • DolasetronA04AA04severe
  • EpinephrineB02BC09severe
  • EpinephrineC01CA24severe
  • OrciprenalinC01CA29severe

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

Labetalol in 14 other countries

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

All labetalol products

Authorised across Europe · EMA

The same active substance is authorised in 18 EEA countries. Names it is sold under:

  • Austria · Trandate
  • Belgium · Trandate
  • Cyprus · Trandate
  • Denmark · Labetalol S.A.L.F., Trandate
  • Estonia · Trandate, Trandate Injection
  • Spain · Labetalol S.A.L.F., Trandate
  • Finland · Albetol, Labetalol S.A.L.F.
  • France · Labetalol Stragen, Trandate
  • United Kingdom (Northern Ireland) · Labetalol Generics Uk, Labetalol S.A.L.F.
  • Ireland · Labetalol S.A.L.F. S.P.A. Laboratorio, Trandate
  • Iceland · Trandate
  • Italy · Labetalolo S.A.L.F., Trandate
  • Luxembourg · Trandate
  • Malta · Labetalol S.A.L.F.
  • Netherlands · Labetalol Hcl Mylan, Trandate Injectie
  • Norway · Labetalol S.A.L.F., Trandate
  • Portugal · Labetalol Pharmakern, Labetalol S.A.L.F.
  • Sweden · Labetalol S.A.L.F., Trandate

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/286ae951-4b9b-4e09-91ce-87db9f40bc81
GET /v1/drugs/286ae951-4b9b-4e09-91ce-87db9f40bc81?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": "400",
  "substance": "LABETALOL HYDROCHLORIDE",
  "productndc": "23155-726",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA074787",
  "marketing_category": "ANDA"
}

See everything about labetalol.

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.