FDA Orange Book
Generic for Mephyton
Mephyton contains phytonadione. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Mephyton is phytonadione. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Mephyton products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 5MG | Discontinued | None | 5 | AB |
NDA 010104, held by BAUSCH HEALTH AMERICAS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic phytonadione
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL PHARMACEUTICALS CO GMBH | 209373 | AB (A-rated, therapeutically equivalent) | May 11, 2018 | 5MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 210189 | AB (A-rated, therapeutically equivalent) | February 20, 2019 | 5MG |
| SCIEGEN PHARMACEUTICALS INC | 213329 | AB (A-rated, therapeutically equivalent) | July 28, 2023 | 5MG |
| TP ANDA HOLDINGS LLC | 213336 | AB (A-rated, therapeutically equivalent) | October 12, 2023 | 5MG |
| NOVAX PRO PHARMA LLC | 220454 | AB (A-rated, therapeutically equivalent) | February 26, 2026 | 5MG |
Questions
Is there a generic for Mephyton?
Yes. The generic name for Mephyton is phytonadione. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Mephyton?
The active ingredient in Mephyton is phytonadione, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.