Is there a generic for Phytonadione?

Yes. The FDA Orange Book lists 24 approved generic (ANDA) applications for Phytonadione, referencing the brand AQUAMEPHYTON. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Phytonadione?

AQUAMEPHYTON (NDA 012223, PAI HOLDINGS PHARM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Phytonadione are approved?

Phytonadione is approved in the following dosage forms: injectable, tablet.

FDA Orange Book · active-ingredient family

Phytonadione

Phytonadione: 3 brands, 24 generics; first approved Jul 25, 1983; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 24 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

AQUAMEPHYTONRLD

PAI HOLDINGS PHARMNDA 012223—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
1MG/0.5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—

MEPHYTONRLD

BAUSCHNDA 010104—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—

KONAKION

ROCHENDA 011745—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/0.5ML	INJECTABLE	INJECTION	Discontinued	—
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

Abbreviated applications

Generic (ANDA) products (24)

PHYTONADIONE

AMNEALANDA 2177342026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AB1

PHYTONADIONE

DR REDDYSANDA 2158202026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/0.5ML	INJECTABLE	INJECTION	Rx	AB1

PHYTONADIONE

ORBICULARANDA 2162982026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/0.5ML	INJECTABLE	INJECTION	Rx	AB1

PHYTONADIONE

BAXTER HLTHCARE CORPANDA 2168522026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/0.5ML	INJECTABLE	INJECTION	Rx	AB2

PHYTONADIONE

SINOTHERAPEUTICS INCANDA 2204542026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

PHYTONADIONE

SUNNYANDA 2150902026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AB1

PHYTONADIONE

AMNEALANDA 2166012025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/0.5ML	INJECTABLE	INJECTION	Rx	AB1

PHYTONADIONE

ALEMBICANDA 2164442025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/0.5ML	INJECTABLE	INJECTION	Rx	AB1

PHYTONADIONE

CAPLINANDA 2192122025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AB1

PHYTONADIONE

CIPLAANDA 2149662025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/0.5ML	INJECTABLE	INJECTION	Rx	AB1

PHYTONADIONE

HIKMAANDA 2121122024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Discontinued	—

PHYTONADIONE

GLANDANDA 2173862024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AB1

PHYTONADIONE

AGNITIOANDA 2133362023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

PHYTONADIONE

SCIEGEN PHARMSANDA 2133292023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

PHYTONADIONE

CIPLAANDA 21242420222 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/0.5ML	INJECTABLE	INJECTION	Discontinued	—
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

PHYTONADIONERS

CIPLAANDA 21459620222 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/0.5ML	INJECTABLE	INJECTION	Rx	AB2
10MG/ML	INJECTABLE	INJECTION	Rx	—

PHYTONADIONE

DR REDDYSANDA 2077192019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AB1

PHYTONADIONERS

ZYDUS LIFESCIENCESANDA 2101892019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

PHYTONADIONE

AMNEAL PHARMS COANDA 2093732018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG	TABLET	ORAL	Rx	AB

VITAMIN K1RLDRS

HOSPIRAANDA 0879541983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/0.5ML	INJECTABLE	INJECTION	Rx	BP

VITAMIN K1RLDRS

HOSPIRAANDA 0879551983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Rx	AB1

VITAMIN K1

HOSPIRAANDA 0879561983

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

PHYTONADIONE

GLAXOSMITHKLINEANDA 084060—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/0.5ML	INJECTABLE	INJECTION	Discontinued	—
10MG/ML	INJECTABLE	INJECTION	Discontinued	—

PHYTONADIONERLDRS

INTL MEDICATIONANDA 083722—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/0.5ML	INJECTABLE	INJECTION	Rx	AB1

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Jul 25, 1983

43 yr 7 mo ago

Most recent approval

Jun 01, 2026

1 mo ago

Approvals span 1983–2026 across 27 FDA applications.

Brand (NDA) 311%

Generic (ANDA) 2489%

Phytonadione — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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