Medicine
Propofol 500 mg/50 mL injectable emulsion
Propofol 500 mg/50 mL injectable emulsion is a generic prescription medicine for intravenous use, made by 12 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 between 4° to 25°C (40° to 77°F).
Key facts
- Active ingredient (INN)
- Propofol
- Brand
- Sold under the generic name
- Strength
- 500 mg/50 mL
- Dosage form
- Injectable emulsion
- Route
- Intravenous
- Packs
- 20 vials of 50 mL, 10 vials of 50 mL, 50 mL and 10 more
- Manufacturers
- Avet PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaHospiraAmneal PharmaceuticalsAvenacyCivicaHealthFirstHikma PharmaceuticalsMeitheal PharmaceuticalsNorthStar Rx
- Origin register
- US FDA, United States
- Storage
- DO NOT FREEZE. Store between 4° to 25°C (40° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N01AX10 Propofol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 April 2006
- Identifiers
- RxCUI 1808217, 1808222, 1808224DailyMed set ID fdb77e13-f5a7-4c4a-9f8e-338b702239c8, 10272dc1-657d-4798-a34a-b6341b92e560, 3acf8e6c-827d-11e2-9e96-0800200c9a66 +9NDC 0641-6195, 23155-345, 0069-0234 +10Application ANDA074848, ANDA206408, ANDA205576 +5
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 |
|---|---|---|---|
| 20 vial in 1 carton / 50 mL in 1 vial | 23155-345-42 | Avet PharmaceuticalsIndia | 2 June 2025 |
| 20 vial in 1 carton / 50 mL in 1 vial | 43598-548-21 | Dr. Reddy's LaboratoriesIndia | 15 November 2018 |
| 20 vial, single-dose in 1 tray / 50 mL in 1 vial, single-dose | 0409-0501-98 | Hospira | 17 August 2026 |
| 20 vial in 1 tray / 50 mL in 1 vial | 0409-4699-33 | Hospira | 3 April 2006 |
| 20 vial in 1 carton / 50 mL in 1 vial | 80830-2364-8 | Amneal Pharmaceuticals | 16 August 2024 |
| 20 vial, single-use in 1 carton / 50 mL in 1 vial, single-use | 0641-6195-20 | Hikma Pharmaceuticals | 1 May 2020 |
| 10 vial in 1 carton / 50 mL in 1 vial | 71288-730-51 | Meitheal Pharmaceuticals | 2 December 2025 |
| 20 vial in 1 carton / 50 mL in 1 vial | 0069-0234-20 | Pfizer Laboratories | 5 October 2020 |
| 20 vial in 1 carton / 50 mL in 1 vial | 25021-608-50 | Sagent Pharmaceuticals | 1 July 2014 |
| 20 vial in 1 carton / 50 mL in 1 vial | 83634-603-50 | Avenacy | 30 April 2025 |
| 20 vial in 1 carton / 50 mL in 1 vial | 72572-601-20 | Civica | 16 July 2021 |
| 50 mL in 1 vial | 51662-1471-1 | HealthFirst | 15 December 2019 |
| 20 vial in 1 carton / 50 mL in 1 vial | 16714-977-20 | NorthStar Rx | 2 June 2025 |
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 2 October 1989 | 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
Alternatives
Other makers and brands of Propofol 500 mg/50 mL injectable emulsion.
Other strengths and forms of Propofol
Clinical summary
Propofol is a general anesthetic indicated for induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age, among other approved uses. It is available as injectable emulsion for intravenous use. MedsAcross supplies Propofol 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 PropofolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Diprivan prescribing information (Fresenius Kabi) · U.S. National Library of Medicine, DailyMed
Need Propofol 500 mg/50 mL injectable emulsion 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.