United States· US:50090-7666_904fbf22-4fe2-47b4-a2ee-514fb4eed012

LABETALOL HYDROCHLORIDE

A labetalol product containing labetalol hydrochloride, registered in United States by A-S Medication Solutions. The same ATC class is registered in 16 of our 19 countries.

ATC C07AG01Orange BookUS label

Checked against FDA National Drug Code directory (United States) on September 12, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about labetalol hydrochlorideAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

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

Search labetalol products by name

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

Open the full comparison — free account Drug prices for market access

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: A-S Medication Solutions
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 12, 2026

Packs & prices · 1

ndc11
5009076661
90 TABLET, FILM COATED in 1 BOTTLE (50090-7666-1)

Regulatory notes

UNII (FDA substance ID)

1GEV3BAW9J

LABETALOL HYDROCHLORIDE

RxCUI 202693

Orange Book

A211953

ABABAB

DailyMed SPL labels

1 version tracked

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

Check labetalol against other medicines How interaction checks work

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.

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/a8f7d2a5-5807-41db-8700-f900fbaf3115
GET /v1/drugs/a8f7d2a5-5807-41db-8700-f900fbaf3115?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.

{
  "unii": {
    "unii": "1GEV3BAW9J",
    "rxcui": "202693",
    "inchikey": "WQVZLXWQESQGIF-UHFFFAOYSA-N",
    "display_name": "LABETALOL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 3
  },
  "spl_meta": {
    "d3ca153c-25b2-4506-91bd-bf9d6a4c01fe": {
      "match": "brand_token",
      "title": "LABETALOL HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]",
      "spl_version": "4",
      "published_date": "2026-06-01"
    }
  },
  "productid": "50090-7666_904fbf22-4fe2-47b4-a2ee-514fb4eed012",
  "productndc": "50090-7666",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211953",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Aug 18, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Aug 18, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Aug 18, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LABETALOL HYDROCHLORIDE",
  "proprietary_name": "LABETALOL HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211953",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Labetalol Hydrochloride",
  "start_marketing_date": "20210818",
  "active_numerator_strength": "300"
}

API reference MCP server Plans

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.

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