FDA Orange Book
Generic for Depen
Depen contains penicillamine. 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 Depen is penicillamine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Depen products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 250MG | Marketed (Rx) | AB | 2 | AB |
NDA 019854, held by MYLAN SPECIALTY LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic penicillamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 211196 | AB (A-rated, therapeutically equivalent) | December 23, 2019 | 250MG |
| LUPIN LTD | 212933 | AB (A-rated, therapeutically equivalent) | November 30, 2020 | 250MG |
Depen NDC codes
Questions
Is there a generic for Depen?
Yes. The generic name for Depen is penicillamine. 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 Depen?
The active ingredient in Depen is penicillamine, 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.