Medicine
Labetalol 200 mg tablet
Labetalol 200 mg tablet is a generic prescription medicine for oral use, made by 24 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Labetalol Hydrochloride Tablets, USP, for oral administration, are available…
Key facts
- Active ingredient (INN)
- Labetalol
- Brand
- Sold under the generic name
- Strength
- 200 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 73 more
- Manufacturers
- Zydus LifesciencesIndiaCadila PharmaceuticalsIndiaBioconIndiaAvet PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaUnichem LaboratoriesIndiaBryant Ranch PrepackEpic PharmaMethod PharmaceuticalsAdvagen Pharma24 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Labetalol Hydrochloride Tablets, USP, for oral administration, are available as 100 mg Round, beige film-coated tablets, plain on one side, scored and debossed with “I/126” on the other side: NDC 10135-0711-01 bottles of 100 NDC 10135-0711-05 bottles of 500 200 mg Round, white film-coated tablets, plain on one side, scored and debossed with “I/127” on the other side: NDC 10135-0712-01 bottles of…
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C07AG01 Labetalol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 August 1998
- Identifiers
- RxCUI 896758, 896762, 896766 +1DailyMed set ID 28c91727-e5a8-48b3-a4df-d7bec8feda40, 371cb135-6a5f-433d-a87d-ab8521c4aa6d, d3ca153c-25b2-4506-91bd-bf9d6a4c01fe +36NDC 10135-712, 50090-7523, 55154-0182 +37Application ANDA075215, ANDA209603, ANDA074787 +8
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
A sample of 40 packs from 24 labelers. The register lists 76 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 68382-799-01 | Zydus LifesciencesIndia | 5 December 2017 |
| 500 tablet, film coated in 1 bottle | 68382-799-05 | Zydus LifesciencesIndia | 5 December 2017 |
| 30 tablet, film coated in 1 bottle | 68382-799-06 | Zydus LifesciencesIndia | 5 December 2017 |
| 90 tablet, film coated in 1 bottle | 68382-799-16 | Zydus LifesciencesIndia | 5 December 2017 |
| 100 tablet, film coated in 1 bottle | 70771-1164-1 | Zydus LifesciencesIndia | 5 December 2017 |
| 30 tablet, film coated in 1 bottle | 70771-1164-3 | Zydus LifesciencesIndia | 5 December 2017 |
| 500 tablet, film coated in 1 bottle | 70771-1164-5 | Zydus LifesciencesIndia | 5 December 2017 |
| 90 tablet, film coated in 1 bottle | 70771-1164-9 | Zydus LifesciencesIndia | 5 December 2017 |
| 100 tablet in 1 bottle | 23155-724-01 | Avet PharmaceuticalsIndia | 22 February 2020 |
| 500 tablet in 1 bottle | 23155-724-05 | Avet PharmaceuticalsIndia | 22 February 2020 |
| 30 tablet, film coated in 1 bottle | 70377-061-11 | BioconIndia | 27 May 2021 |
| 100 tablet, film coated in 1 bottle | 70377-061-12 | BioconIndia | 27 May 2021 |
| 500 tablet, film coated in 1 bottle | 70377-061-13 | BioconIndia | 27 May 2021 |
| 60 tablet, film coated in 1 bottle | 71209-084-03 | Cadila PharmaceuticalsIndia | 30 June 2018 |
| 100 tablet, film coated in 1 bottle | 71209-084-05 | Cadila PharmaceuticalsIndia | 24 November 2022 |
| 500 tablet, film coated in 1 bottle | 71209-084-10 | Cadila PharmaceuticalsIndia | 24 November 2022 |
| 1000 tablet, film coated in 1 bottle | 71209-084-11 | Cadila PharmaceuticalsIndia | 30 June 2018 |
| 100 tablet, film coated in 1 bottle | 33342-516-11 | Macleods PharmaceuticalsIndia | 23 September 2025 |
| 500 tablet, film coated in 1 bottle | 33342-516-15 | Macleods PharmaceuticalsIndia | 23 September 2025 |
| 100 tablet, film coated in 1 bottle | 29300-253-01 | Unichem LaboratoriesIndia | 1 October 2022 |
| 500 tablet, film coated in 1 bottle | 29300-253-05 | Unichem LaboratoriesIndia | 1 October 2022 |
| 100 tablet, film coated in 1 bottle | 58657-603-01 | Method Pharmaceuticals | 22 November 2019 |
| 500 tablet, film coated in 1 bottle | 58657-603-50 | Method Pharmaceuticals | 22 November 2019 |
| 100 blister pack in 1 carton / 100 tablet, film coated in 1 blister pack | 58657-907-01 | Method Pharmaceuticals | 1 July 2025 |
| 100 tablet, film coated in 1 bottle | 72888-121-01 | Advagen Pharma | 18 August 2021 |
| 500 tablet, film coated in 1 bottle | 72888-121-05 | Advagen Pharma | 18 August 2021 |
| 60 tablet in 1 bottle | 62135-792-60 | Chartwell RX | 24 October 2023 |
| 100 tablet in 1 bottle | 42806-328-01 | Epic Pharma | 30 September 2021 |
| 500 tablet in 1 bottle | 42806-328-05 | Epic Pharma | 30 September 2021 |
| 1000 tablet in 1 bottle | 42806-328-10 | Epic Pharma | 30 September 2021 |
| 100 tablet, film coated in 1 bottle | 71247-127-01 | Innogenix | 8 February 2021 |
| 500 tablet, film coated in 1 bottle | 71247-127-05 | Innogenix | 8 February 2021 |
| 100 tablet, film coated in 1 bottle | 63629-1163-1 | Bryant Ranch Prepack | 22 November 2019 |
| 500 tablet, film coated in 1 bottle | 63629-1164-1 | Bryant Ranch Prepack | 2 October 2020 |
| 30 tablet, film coated in 1 bottle | 71335-1242-1 | Bryant Ranch Prepack | 27 November 2019 |
| 90 tablet, film coated in 1 bottle | 71335-1242-2 | Bryant Ranch Prepack | 23 July 2021 |
| 60 tablet, film coated in 1 bottle | 71335-1242-3 | Bryant Ranch Prepack | 6 June 2019 |
| 30 tablet, film coated in 1 bottle | 71335-2057-1 | Bryant Ranch Prepack | 3 April 2024 |
| 90 tablet, film coated in 1 bottle | 71335-2057-2 | Bryant Ranch Prepack | 3 April 2024 |
| 60 tablet, film coated in 1 bottle | 71335-2057-3 | Bryant Ranch Prepack | 3 March 2022 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 1 August 1984 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Labetalol
Clinical summary
Labetalol is a beta-adrenergic blocker indicated in severe hypertension, to lower blood pressure. It is available as tablets and injection for oral and intravenous use. MedsAcross supplies Labetalol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about LabetalolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Labetalol Hydrochloride prescribing information (Hikma Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Labetalol 200 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.