FDA Orange Book
Is there a generic for Ryanodex?
Ryanodex contains dantrolene. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ryanodex (dantrolene).
Run it in Rivvi
Map Ryanodex and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Ryanodex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, intravenous | 250MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 205579, held by EAGLE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ryanodex NDC codes
Questions
Is there a generic for Ryanodex?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ryanodex (dantrolene).
What is the generic name for Ryanodex?
The active ingredient in Ryanodex is dantrolene, 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.