FDA Orange Book
Is there a generic for Emsam?
Emsam contains selegiline. 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 Emsam (selegiline).
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Emsam products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| film, extended release, transdermal | 12MG/24HR | Marketed (Rx) | None | 0 | None |
| film, extended release, transdermal | 6MG/24HR | Marketed (Rx) | None | 0 | None |
| film, extended release, transdermal | 9MG/24HR | Marketed (Rx) | None | 0 | None |
NDA 021336, held by SOMERSET PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Emsam NDC codes
Questions
Is there a generic for Emsam?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Emsam (selegiline).
What is the generic name for Emsam?
The active ingredient in Emsam is selegiline, 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.
More on Emsam and Selegiline
- What is Selegiline used for?FDA label uses
- Is Selegiline a controlled substance?Federal schedule
- Generic for EldeprylFDA Orange Book
- Monoamine Oxidase Inhibitors listFDA drug class
- Monoamine Oxidase Type B Inhibitors listFDA drug class
- NDC 49502-900Emsam NDC record
- NDC 49502-901Emsam NDC record
- NDC 49502-902Emsam NDC record