FDA Orange Book
Generic for Ampyra
Ampyra contains dalfampridine. 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 Ampyra is dalfampridine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Ampyra 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.
Ampyra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 10MG | Marketed (Rx) | AB | 5 | AB |
NDA 022250, held by MERZ PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dalfampridine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES FL INC | 206836 | AB (A-rated, therapeutically equivalent) | January 23, 2017 | 10MG |
| AUROBINDO PHARMA LTD | 206811 | AB (A-rated, therapeutically equivalent) | January 23, 2017 | 10MG |
| ACCORD HEALTHCARE INC | 206863 | AB (A-rated, therapeutically equivalent) | July 11, 2018 | 10MG |
| ALKEM LABORATORIES LTD | 206765 | AB (A-rated, therapeutically equivalent) | July 30, 2018 | 10MG |
| MICRO LABS LTD | 210158 | AB (A-rated, therapeutically equivalent) | March 11, 2019 | 10MG |
Ampyra NDC codes
Questions
Is there a generic for Ampyra?
Yes. The generic name for Ampyra is dalfampridine. 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 Ampyra?
The active ingredient in Ampyra is dalfampridine, 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.