FDA Orange Book
Generic for Dyrenium
Dyrenium contains triamterene. 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 Dyrenium is triamterene. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Dyrenium 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 | 50MG | Marketed (Rx) | AB | 2 | AB |
NDA 013174, held by ADVANZ PHARMA (US) CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic triamterene
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TP ANDA HOLDINGS LLC | 211581 | AB (A-rated, therapeutically equivalent) | August 19, 2019 | 100MG, 50MG |
| BIOCON GENERICS INC | 214768 | AB (A-rated, therapeutically equivalent) | July 6, 2022 | 100MG, 50MG |
Dyrenium NDC codes
Questions
Is there a generic for Dyrenium?
Yes. The generic name for Dyrenium is triamterene. 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 Dyrenium?
The active ingredient in Dyrenium is triamterene, 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.