Medicine
Sezaby 100 mg injection
Sezaby 100 mg injection is a prescription medicine containing Phenobarbital for intravenous use, marketed by Sun Pharmaceutical Industries, 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
Store unopened vials of SEZABY in original cartons at 20°C to 25°C (68°F to…
Key facts
- Active ingredient (INN)
- Phenobarbital
- Brand
- Sezaby
- Strength
- 100 mg
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 injection
- Marketing authorisation holder
- Sun Pharmaceutical Industries
- Manufacturer
- Sun Pharmaceutical IndustriesIndia
- Origin register
- US FDA, United States
- Storage
- Store unopened vials of SEZABY in original cartons at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Retain in the original carton until use to protect from light. For information on storage of the reconstituted SEZABY, see Dosage and Administration.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Schedule CIV
- ATC code
- N03AA02 Phenobarbital
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 December 2022
- Identifiers
- RxCUI 2624719, 2624724DailyMed set ID 8c7d0402-4977-4c25-bc4b-11db91339e9aNDC 62756-301Application NDA215910
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 injection in 1 vial, single-dose | 62756-301-01 | Sun Pharmaceutical IndustriesIndia | 26 December 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 17 November 2022 | 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
Clinical summary
Phenobarbital is a prescription medicine indicated for the treatment of neonatal seizures in term and preterm infants. It is available as injection for intravenous use. MedsAcross supplies Phenobarbital 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 PhenobarbitalFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SEZABY prescribing information (Sun Pharmaceutical Industries) · U.S. National Library of Medicine, DailyMed
Need Sezaby 100 mg 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.