FDA Orange Book
Generic for Cerebyx
Cerebyx contains fosphenytoin. 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 Cerebyx is fosphenytoin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Cerebyx products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 50MG PHENYTOIN NA/ML | Marketed (Rx) | AP | 7 | AP |
NDA 020450, held by PARKE DAVIS DIV WARNER LAMBERT CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fosphenytoin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 078052 | AP (A-rated, therapeutically equivalent) | August 6, 2007 | EQ 50MG PHENYTOIN NA/ML |
| HIKMA PHARMACEUTICALS USA INC | 077481 | AP (A-rated, therapeutically equivalent) | August 6, 2007 | EQ 50MG PHENYTOIN NA/ML |
| HIKMA PHARMACEUTICALS USA INC | 077989 | AP (A-rated, therapeutically equivalent) | August 6, 2007 | EQ 50MG PHENYTOIN NA/ML |
| WOCKHARDT BIO AG | 078137 | AP (A-rated, therapeutically equivalent) | August 6, 2007 | EQ 50MG PHENYTOIN NA/ML |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 078417 | AP (A-rated, therapeutically equivalent) | March 18, 2008 | EQ 50MG PHENYTOIN NA/ML |
| HIKMA FARMACEUTICA (PORTUGAL) SA | 078765 | AP (A-rated, therapeutically equivalent) | December 2, 2009 | EQ 50MG PHENYTOIN NA/ML |
| GLAND PHARMA LTD | 214926 | AP (A-rated, therapeutically equivalent) | October 13, 2023 | EQ 50MG PHENYTOIN NA/ML |
Cerebyx NDC codes
Questions
Is there a generic for Cerebyx?
Yes. The generic name for Cerebyx is fosphenytoin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Cerebyx?
The active ingredient in Cerebyx is fosphenytoin, 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.