FDA Orange Book
Generic for Dantrium
Dantrium 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
Yes. The generic name for Dantrium is dantrolene. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Dantrium products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | AB | 2 | AB |
| capsule, oral | 25MG | Marketed (Rx) | AB | 2 | AB |
| capsule, oral | 50MG | Marketed (Rx) | AB | 2 | AB |
| injectable, injection | 20MG/VIAL | Marketed (Rx) | AP | 2 | AP |
NDA 017443, 018264, held by PH HEALTH LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dantrolene
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| IMPAX LABORATORIES INC | 076856 | AB (A-rated, therapeutically equivalent) | March 1, 2005 | 100MG, 25MG, 50MG |
| ELITE LABORATORIES INC | 076686 | AB (A-rated, therapeutically equivalent) | October 24, 2005 | 100MG, 25MG, 50MG |
| USWM LLC | 078378 | AP (A-rated, therapeutically equivalent) | July 24, 2007 | 20MG/VIAL |
| HIKMA PHARMACEUTICALS LLC | 204762 | AP (A-rated, therapeutically equivalent) | June 19, 2017 | 20MG/VIAL |
Dantrium NDC codes
Questions
Is there a generic for Dantrium?
Yes. The generic name for Dantrium is dantrolene. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Dantrium?
The active ingredient in Dantrium 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.