Medicine
Phytonadione 10 mg/1 mL injectable emulsion
Phytonadione 10 mg/1 mL injectable emulsion is a generic prescription medicine for intramuscular, intravenous, subcutaneous use, made by 10 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
Store at 20 to 25°C (68 to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Phytonadione
- Brand
- Sold under the generic name
- Strength
- 10 mg/1 mL
- Dosage form
- Injectable emulsion
- Route
- Intramuscular, intravenous, subcutaneous
- Packs
- 2 trays of 1 mL, 10 vials of 1 mL, 25 ampules of 1 mL and 8 more
- Manufacturers
- Caplin SterilesIndiaCiplaIndiaDr. Reddy's LaboratoriesIndiaGland PharmaIndiaGlenmark PharmaceuticalsIndiaHealthFirstAmneal PharmaceuticalsFresenius KabiHenry ScheinXiromed
- Origin register
- US FDA, United States
- Storage
- 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
- B02BA01 Phytonadione
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 May 2019
- Identifiers
- RxCUI 1670192, 312424DailyMed set ID 5686f34b-446a-00ae-e063-6394a90a6029, ddd351d3-8b9e-482d-9ab8-f367ce1c3cc0, c375bfab-5a4b-40f3-a783-8372158af860 +8NDC 51662-1698, 80830-1683, 68083-606 +8Application ANDA207719, ANDA217734, ANDA217386 +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 |
|---|---|---|---|
| 2 tray in 1 carton / 5 vial, single-dose in 1 tray / 1 mL in 1 vial, single-dose | 65145-151-10 | Caplin SterilesIndia | 26 April 2025 |
| 10 vial in 1 carton / 1 mL in 1 vial | 69097-708-96 | CiplaIndia | 27 April 2022 |
| 25 ampule in 1 carton / 1 mL in 1 ampule | 43598-405-16 | Dr. Reddy's LaboratoriesIndia | 31 May 2019 |
| 5 tray in 1 carton / 5 ampule in 1 tray / 1 mL in 1 ampule | 68083-606-25 | Gland PharmaIndia | 10 December 2024 |
| 5 tray in 1 carton / 5 ampule in 1 tray / 1 mL in 1 ampule | 68462-758-25 | Glenmark PharmaceuticalsIndia | 10 December 2024 |
| 5 tray in 1 carton / 5 vial, glass in 1 tray / 1 mL in 1 vial, glass | 80830-1683-3 | Amneal Pharmaceuticals | 1 June 2026 |
| 2 tray in 1 carton / 5 vial, single-dose in 1 tray / 1 mL in 1 vial, single-dose | 65219-635-01 | Fresenius Kabi | 10 May 2025 |
| 5 tray in 1 carton / 5 ampule in 1 tray / 1 mL in 1 ampule | 70700-331-25 | Xiromed | 28 August 2025 |
| 25 pouch in 1 box / 1 ampule in 1 pouch / 1 mL in 1 ampule | 51662-1536-3 | HealthFirst | 10 May 2021 |
| 25 pouch in 1 case / 1 ampule in 1 pouch / 1 mL in 1 ampule | 51662-1698-3 | HealthFirst | 31 May 2019 |
| 1 ampule in 1 bag / 1 mL in 1 ampule | 0404-9969-01 | Henry Schein | 10 January 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 30 September 1955 | 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 Phytonadione 10 mg/1 mL injectable emulsion.
Other strengths and forms of Phytonadione
Clinical summary
Phytonadione is a vitamin K indicated for the treatment of coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. MedsAcross supplies Phytonadione 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 PhytonadioneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Phytonadione prescribing information (Dr. Reddy's Laboratories) · U.S. National Library of Medicine, DailyMed
Need Phytonadione 10 mg/1 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.