FDA Orange Book
Generic for Dexedrine Spansule
Dexedrine Spansule contains dextroamphetamine. 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 Dexedrine Spansule is dextroamphetamine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Dexedrine Spansule products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 10MG | Marketed (Rx) | AB | 2 | AB |
| capsule, extended release, oral | 15MG | Marketed (Rx) | AB | 2 | AB |
| capsule, extended release, oral | 5MG | Marketed (Rx) | AB | 2 | AB |
NDA 017078, held by IMPAX LABORATORIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dextroamphetamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SPECGX LLC | 076353 | AB (A-rated, therapeutically equivalent) | May 6, 2003 | 10MG, 15MG, 5MG |
| ACTAVIS ELIZABETH LLC | 203901 | AB (A-rated, therapeutically equivalent) | November 30, 2012 | 10MG, 15MG, 5MG |
Dexedrine Spansule NDC codes
Questions
Is there a generic for Dexedrine Spansule?
Yes. The generic name for Dexedrine Spansule is dextroamphetamine. 2 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 Dexedrine Spansule?
The active ingredient in Dexedrine Spansule is dextroamphetamine, 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.