Medicine
Phytonadione 5 mg tablet
Phytonadione 5 mg tablet is a generic prescription medicine for oral 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
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to…
Key facts
- Active ingredient (INN)
- Phytonadione
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle, 30 tablets, 10 blister pack and 12 more
- Manufacturers
- Zydus LifesciencesIndiaCiplaIndiaAmneal Pharmaceuticals NYScieGen PharmaceuticalsAgnitioAmerican Health PackagingCouplerExelan PharmaceuticalsMajor PharmaceuticalsPadagis12 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Store in tightly closed original container and 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
- 15 May 2018
- Identifiers
- RxCUI 198102DailyMed set ID 66ada4f8-c5a9-49f1-848f-e172416892a1, 7dd1f275-94d3-45d2-a4d0-696ce60a2a9b, 68701a07-2921-4443-bff3-76e261a9eb18 +10NDC 72134-008, 69097-999, 0574-1850 +10Application ANDA213336, ANDA213329, ANDA220454 +2
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 bottle in 1 carton / 100 tablet in 1 bottle | 70771-1318-1 | Zydus LifesciencesIndia | 22 February 2019 |
| 30 tablet in 1 bottle | 70771-1318-3 | Zydus LifesciencesIndia | 1 November 2021 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 70771-1318-4 | Zydus LifesciencesIndia | 22 February 2019 |
| 30 tablet in 1 bottle | 69097-999-02 | CiplaIndia | 1 December 2023 |
| 100 tablet in 1 bottle | 69097-999-07 | CiplaIndia | 1 December 2023 |
| 100 tablet in 1 bottle | 72134-008-01 | Agnitio | 11 February 2022 |
| 1 bottle in 1 carton / 100 tablet in 1 bottle | 69238-1051-1 | Amneal Pharmaceuticals NY | 15 May 2018 |
| 1 bottle in 1 carton / 30 tablet in 1 bottle | 69238-1051-3 | Amneal Pharmaceuticals NY | 15 May 2018 |
| 1 bottle in 1 carton / 30 tablet in 1 bottle | 76282-740-30 | Exelan Pharmaceuticals | 1 December 2023 |
| 1 bottle in 1 carton / 30 tablet in 1 bottle | 0574-1850-30 | Padagis | 28 October 2026 |
| 1 bottle in 1 carton / 100 tablet in 1 bottle | 50228-333-01 | ScieGen Pharmaceuticals | 28 July 2023 |
| 1 bottle in 1 carton / 30 tablet in 1 bottle | 50228-333-30 | ScieGen Pharmaceuticals | 28 July 2023 |
| 20 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack | 60687-381-94 | American Health Packaging | 21 June 2018 |
| 30 tablet in 1 blister pack | 67046-1581-3 | Coupler | 8 September 2025 |
| 20 blister pack in 1 carton / 1 tablet in 1 blister pack | 0904-6882-10 | Major Pharmaceuticals | 15 May 2018 |
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
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 5 mg tablet 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.