Medicine
Phytonadione 1 mg/0.5 mL injectable emulsion
Phytonadione 1 mg/0.5 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), excursions permitted between 15° and 30°C…
Key facts
- Active ingredient (INN)
- Phytonadione
- Brand
- Sold under the generic name
- Strength
- 1 mg/0.5 mL
- Dosage form
- Injectable emulsion
- Route
- Intramuscular, intravenous, subcutaneous
- Packs
- 1 syringe of 0.5 mL, 10 syringes of 0.5 mL, 10 vials of 0.5 mL and 11 more
- Manufacturers
- Alembic PharmaceuticalsIndiaCiplaIndiaDr. Reddy's LaboratoriesIndiaOrbicular Pharmaceutical TechnologiesIndiaSun Pharmaceutical IndustriesIndiaAmneal PharmaceuticalsBaxter HealthcareHealthFirstInternational Medication SystemsSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F). Protect from light. Store container in closed original carton until contents have been used.
- 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
- 18 April 2003
- Identifiers
- RxCUI 727625, 312424, 1670192DailyMed set ID 3d571642-3d3a-41ae-855e-304ae4fff459, 226c0a5c-3e04-65a9-01ac-e67aad9a430a, b1e53422-c85d-4bb6-af4f-24934cc319b0 +9NDC 25021-505, 43598-032, 62332-826 +9Application ANDA216444, ANDA215820, ANDA087954 +6
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 syringe in 1 carton / .5 mL in 1 syringe | 46708-826-05 | Alembic PharmaceuticalsIndia | 8 September 2025 |
| 10 syringe in 1 carton / .5 mL in 1 syringe | 46708-826-10 | Alembic PharmaceuticalsIndia | 8 September 2025 |
| 1 syringe in 1 carton / .5 mL in 1 syringe | 62332-826-05 | Alembic PharmaceuticalsIndia | 8 September 2025 |
| 10 syringe in 1 carton / .5 mL in 1 syringe | 62332-826-10 | Alembic PharmaceuticalsIndia | 8 September 2025 |
| 10 syringe in 1 carton / .5 mL in 1 syringe | 69097-003-96 | CiplaIndia | 15 January 2025 |
| 10 vial in 1 carton / .5 mL in 1 vial | 69097-709-96 | CiplaIndia | 27 April 2022 |
| 10 carton in 1 box / 1 syringe, glass in 1 carton / .5 mL in 1 syringe, glass | 43598-032-37 | Dr. Reddy's LaboratoriesIndia | 5 October 2026 |
| 10 carton in 1 carton / 1 blister pack in 1 carton / 1 syringe in 1 blister pack / .5 mL in 1 syringe | 81607-020-02 | Orbicular Pharmaceutical TechnologiesIndia | 24 March 2026 |
| 10 carton in 1 carton / 1 blister pack in 1 carton / 1 syringe in 1 blister pack / .5 mL in 1 syringe | 70095-154-02 | Sun Pharmaceutical IndustriesIndia | 10 June 2026 |
| 10 tray in 1 carton / 1 syringe, glass in 1 tray / .5 mL in 1 syringe, glass | 70121-1682-7 | Amneal Pharmaceuticals | 4 November 2025 |
| 10 vial, single-dose in 1 carton / .5 mL in 1 vial, single-dose | 43066-132-10 | Baxter Healthcare | 26 February 2026 |
| 1 syringe in 1 carton / .5 mL in 1 syringe | 76329-1240-1 | International Medication Systems | 18 April 2003 |
| 10 syringe in 1 carton / .5 mL in 1 syringe | 25021-505-70 | Sagent Pharmaceuticals | 1 February 2026 |
| 25 pouch in 1 box / 1 ampule in 1 pouch / .5 mL in 1 ampule | 51662-1537-3 | HealthFirst | 1 November 2021 |
| 1 box in 1 bag / 1 syringe in 1 box / .5 mL in 1 syringe | 0404-9935-05 | — | 13 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 1 mg/0.5 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 1 mg/0.5 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.