Active substance
Labetalol
- SFDA 17
- US FDA 35
- Health Canada 10
- US price lines 5
- NHS prices 3
- Safety 7
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| LABETALOL SALF | 5 mg/ml | Solution for injection/infusion · Intravenous use | 5 Ampoule | SAR 44.90 | Generic · Prescription | S.A.L.F. S.p.A. Laboratorio Farmacologico | Valid |
| Labetalol PSI 100 mg per 20 ml | 5 mg/ml | Solution for injection/infusion · Intravenous use | 1 Vial | SAR 8.40 | Generic · Prescription | Pharmaceutical Solutions Industry Ltd | Valid |
| Labirol 100 mg per 20 ml | 5 mg/ml | Solution for injection · Intravenous use | 5 Vial | SAR 44.90 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| TRANDATE 100MG TABLET | 100 mg | Film-coated tablet · Oral use | 100 Tablet Container | SAR 46.50 | NCE · Prescription | ASPEN PHARMA TRADING LIMITED (APTL) | Valid |
| TRANDATE INJ. 100 MG.-AMP.20ML | 100 mg | Solution for injection · Intravenous use | 5 Ampoule | SAR 44.90 | NCE · Prescription | ASPEN PHARMA TRADING LIMITED (APTL) | Valid |
| TRANDATE TAB 200 MG. | 200 mg | Tablet · Oral use | 100 Tablet Container | SAR 63.60 | NCE · Prescription | ASPEN PHARMA TRADING LIMITED (APTL) | Valid |
| TRANDATE 100MG TABLET | 100 mg | Film-coated tablet · Oral use | 25 Tablet Container | SAR 16.20 | Generic · Prescription | ASPEN | Withdrawn by MAH · Not Marketed |
| TRANDATE 100MG TABLET | 100 mg | Film-coated tablet · Oral use | 25 Tablet Container | SAR 16.20 | Generic · Prescription | ASPEN | Withdrawn by MAH · Not Marketed |
| TRANDATE 100MG TABLET | 100 mg | Film-coated tablet · Oral use | 100 Tablet Container | SAR 46.50 | NCE · Prescription | ASPEN | Withdrawn by MAH · Not Marketed |
| TRANDATE INJ. 100 MG.-AMP.20ML | 100 mg | Solution · Intravenous use | 5 Ampoule | SAR 88.15 | NCE · Prescription | GLAXO | Withdrawn by MAH · Not Marketed |
| TRANDATE INJ. 100 MG.-AMP.20ML | 100 mg | Solution for injection · Intravenous use | 5 Ampoule | SAR 59.90 | NCE · Prescription | ASPEN | Withdrawn by MAH · Not Marketed |
| TRANDATE TAB 100 MG. | 100 mg | Tablet · Oral use | 100 Tablet Container | SAR 46.50 | NCE · Prescription | GLAXO | Withdrawn by MAH · Not Marketed |
| TRANDATE TAB 200 MG. | 200 mg | Tablet · Oral use | 25 Blister | SAR 18.30 | NCE · Prescription | ASPEN | Withdrawn by MAH · Not Marketed |
| TRANDATE TAB 200 MG. | 200 mg | Tablet · Oral use | 25 Blister | SAR 18.30 | NCE · Prescription | GLAXO | Withdrawn by MAH · Not Marketed |
| TRANDATE TAB 200 MG. | 200 mg | Tablet · Oral use | 100 Tablet Container | SAR 63.60 | NCE · Prescription | GLAXO | Withdrawn by MAH · Not Marketed |
| TRANDATE TAB 200 MG. | 200 mg | Tablet · Oral use | 25 Tablet Container | SAR 18.30 | NCE · Prescription | ASPEN PHARMA TRADING LIMITED (APTL) | Withdrawn by MAH · Not Marketed |
| TRANDATE TAB 200 MG. | 200 mg | Tablet · Oral use | 100 Tablet Container | SAR 63.60 | NCE · Prescription | ASPEN | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
HYPERTENSION
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| LABETALOL HYDROCHLORIDE | 100MG; 200MG; 300MG; 400MG | tablet · oral | HERITAGE PHARMA | Prescription | 3 Aug 1998 |
| LABETALOL HYDROCHLORIDE | 100MG; 200MG; 300MG | tablet · oral | WATSON LABS | Prescription | 3 Aug 1998 |
| LABETALOL HYDROCHLORIDE | 100MG; 200MG; 300MG | tablet · oral | AIPING PHARM INC | Prescription | 4 Aug 1998 |
| LABETALOL HYDROCHLORIDE | 5MG/ML | injectable · injection | HIKMA PHARMS | Prescription | 28 May 1999 |
| LABETALOL HYDROCHLORIDE | 100MG; 200MG; 300MG | tablet · oral | INNOGENIX | Prescription | 29 Jul 1999 |
| LABETALOL HYDROCHLORIDE | 5MG/ML | injectable · injection | HOSPIRA | Prescription | 29 Nov 1999 |
| LABETALOL HYDROCHLORIDE | 5MG/ML | injectable · injection | HOSPIRA | Prescription | 29 Nov 1999 |
| LABETALOL HYDROCHLORIDE | 5MG/ML | injectable · injection | RISING | Prescription | 29 Nov 1999 |
| LABETALOL HYDROCHLORIDE | 5MG/ML | injectable · injection | BAXTER HLTHCARE CORP | Prescription | 5 Jul 2002 |
| LABETALOL HYDROCHLORIDE | 5MG/ML | injectable · injection | GLAND PHARMA LTD | Prescription | 3 Apr 2012 |
| LABETALOL HYDROCHLORIDE | 100MG; 200MG; 300MG | tablet · oral | ZYDUS PHARMS | Prescription | 19 Sep 2017 |
| LABETALOL HYDROCHLORIDE | 100MG; 200MG; 300MG; 400MG | tablet · oral | APPCO | Prescription | 20 Jun 2018 |
| LABETALOL HYDROCHLORIDE | 100MG; 200MG; 300MG | tablet · oral | ADAPTIS | Prescription | 4 Feb 2019 |
| LABETALOL HYDROCHLORIDE | 100MG; 200MG; 300MG | tablet · oral | CADILA PHARMS LTD | Prescription | 13 May 2019 |
| LABETALOL HYDROCHLORIDE | 100MG; 200MG; 300MG | tablet · oral | EPIC PHARMA LLC | Prescription | 30 Sep 2020 |
| LABETALOL HYDROCHLORIDE IN DEXTROSE | 200MG/200ML (1MG/ML) | solution · intravenous | HIKMA PHARMS | Prescription | 9 Nov 2020 |
| LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE | 100MG/100ML (1MG/ML); 200MG/200ML (1MG/ML); 300MG/300ML (1MG/ML) | solution · intravenous | HIKMA PHARMS | Prescription | 9 Nov 2020 |
| LABETALOL HYDROCHLORIDE | 20MG/4ML (5MG/ML) | solution · intravenous | HIKMA PHARMS | Prescription | 9 Nov 2020 |
| LABETALOL HYDROCHLORIDE | 100MG; 200MG; 300MG | tablet · oral | RUBICON RESEARCH | Prescription | 18 Aug 2021 |
| LABETALOL HYDROCHLORIDE | 5MG/ML | injectable · injection | CAPLIN | Prescription | 7 Sep 2021 |
| LABETALOL HYDROCHLORIDE | 100MG; 200MG; 300MG | tablet · oral | UNICHEM | Prescription | 8 Aug 2022 |
| LABETALOL HYDROCHLORIDE | 100MG; 200MG; 300MG | tablet · oral | MACLEODS PHARMS LTD | Prescription | 23 Sep 2025 |
| LABETALOL HYDROCHLORIDE | 5MG/ML | injectable · injection | AMNEAL | Prescription | 2 Oct 2025 |
| NORMODYNE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | SCHERING | Discontinued | 1 Aug 1984 |
| NORMODYNE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | SCHERING | Discontinued | 1 Aug 1984 |
10 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-LABETALOL | 02243538 | 100 MG | TABLET · ORAL | APOTEX INC |
| APO-LABETALOL | 02243539 | 200 MG | TABLET · ORAL | APOTEX INC |
| LABETALOL HYDROCHLORIDE INJECTION | 02457040 | 5 MG / ML | SOLUTION · INTRAVENOUS | OMEGA LABORATORIES LIMITED |
| LABETALOL HYDROCHLORIDE INJECTION USP | 02231689 | 5 MG / ML | SOLUTION · INTRAVENOUS | SANDOZ CANADA INCORPORATED |
| LABETALOL HYDROCHLORIDE INJECTION USP | 02385120 | 5 MG / ML | SOLUTION · INTRAVENOUS | STERIMAX INC |
| LABETALOL HYDROCHLORIDE INJECTION USP | 02541505 | 5 MG / ML | SOLUTION · INTRAVENOUS | JAMP PHARMA CORPORATION |
| RIVA-LABETALOL | 02489406 | 100 MG | TABLET · ORAL | LABORATOIRE RIVA INC. |
| RIVA-LABETALOL | 02489414 | 200 MG | TABLET · ORAL | LABORATOIRE RIVA INC. |
| TRANDATE | 02106272 | 100 MG | TABLET · ORAL | KNIGHT THERAPEUTICS INC. |
| TRANDATE | 02106280 | 200 MG | TABLET · ORAL | KNIGHT THERAPEUTICS INC. |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | LABETALOL HCL 100 MG TABLET | $0.08397 | per EA | 30 Sep 2026 |
| US NADAC | LABETALOL HCL 100 MG/20 ML VL | $0.1852 | per ML | 23 Sep 2026 |
| US NADAC | LABETALOL HCL 200 MG TABLET | $0.13952 | per EA | 23 Sep 2026 |
| US NADAC | LABETALOL HCL 300 MG TABLET | $0.21462 | per EA | 30 Sep 2026 |
| US NADAC | LABETALOL HCL 400 MG TABLET | $1.55254 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Labetalol 100mg tablets | £10.12 | 56 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Labetalol 200mg tablets | £22.78 | 56 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Labetalol 400mg tablets | £21.12 | 56 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 25 Apr 2024 TRANDATE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 15 Jun 2023 LABETALOL HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 15 Jun 2023 LABETALOL HYDROCHLORIDE IN DEXTROSE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 15 Jun 2023 LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 28 Oct 2021 PRAC signal: Nipple pain and suppressed lactation
Action for MAH: update of the product information: Yes - EMA PRAC 6 May 2021 PRAC signal: Nipple pain and suppressed lactation
Action for MAH: update of the product information: No - EMA PRAC 14 Jan 2021 PRAC signal: Nipple pain and suppressed lactation
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.