Medicine
Labetalol 100 mg/20 mL injection
Labetalol 100 mg/20 mL injection is a generic prescription medicine for intravenous use, made by 13 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
Do not freeze. Store at 20° to 25°C (68° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Labetalol
- Brand
- Sold under the generic name
- Strength
- 100 mg/20 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 20 mL, 10 vials of 20 mL, 25 vials of 20 mL and 12 more
- Manufacturers
- Caplin SterilesIndiaGland PharmaIndiaHealthFirstHikma PharmaceuticalsArmas PharmaceuticalsBaxter HealthcareCivicaFosun PharmaHospiraMullan Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 20° to 25°C (68° to 77°F). Protect from light.
- 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
- 29 November 1999
- Identifiers
- RxCUI 896771, 2477889DailyMed set ID e76c4b37-4a34-249d-e053-2995a90aa9be, 4a5ffab2-a3b8-411e-992d-7f38d508643a, 48caf986-3126-48e1-afcd-16d65c9cfe00 +11NDC 51662-1602, 72266-102, 68083-111 +11Application ANDA075303, ANDA090699, ANDA214533 +3
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, multi-dose in 1 carton / 20 mL in 1 vial, multi-dose | 65145-124-01 | Caplin SterilesIndia | 14 February 2025 |
| 10 vial, glass in 1 carton / 20 mL in 1 vial, glass | 68083-111-01 | Gland PharmaIndia | 19 April 2012 |
| 1 vial in 1 box, unit-dose / 20 mL in 1 vial | 0143-9320-01 | Hikma Pharmaceuticals | 29 November 1999 |
| 1 vial in 1 box, unit-dose / 20 mL in 1 vial | 0143-9622-01 | Hikma Pharmaceuticals | 29 November 1999 |
| 1 vial, multi-dose in 1 carton / 20 mL in 1 vial, multi-dose | 72485-515-01 | Armas Pharmaceuticals | 15 September 2026 |
| 1 vial in 1 carton / 20 mL in 1 vial | 36000-322-02 | Baxter Healthcare | 26 January 2021 |
| 1 vial, multi-dose in 1 carton / 20 mL in 1 vial, multi-dose | 72266-102-01 | Fosun Pharma | 2 April 2019 |
| 25 vial, multi-dose in 1 tray / 20 mL in 1 vial, multi-dose | 0409-0125-25 | Hospira | 7 August 2023 |
| 1 vial, multi-dose in 1 carton / 20 mL in 1 vial, multi-dose | 83301-0058-1 | Mullan Pharmaceutical | 5 December 2025 |
| 1 vial, multi-dose in 1 carton / 20 mL in 1 vial, multi-dose | 83270-178-01 | Onesource Specialty Pharma | 27 February 2026 |
| 1 vial in 1 carton / 20 mL in 1 vial | 25021-317-20 | Sagent Pharmaceuticals | 1 September 2022 |
| 1 vial in 1 box, unit-dose / 20 mL in 1 vial | 72572-350-01 | Civica | 21 November 2019 |
| 1 vial in 1 box, unit-dose / 20 mL in 1 vial | 51662-1602-1 | HealthFirst | 29 August 2022 |
| 20 mL in 1 vial | 51662-1602-9 | HealthFirst | 1 October 2022 |
| 1 vial, multi-dose in 1 carton / 20 mL in 1 vial, multi-dose | 72603-146-01 | NorthStar Rx | 28 April 2023 |
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 100 mg/20 mL injection 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.