FDA Orange Book
Generic for Moduretic 5-50
Moduretic 5-50 contains amiloride and hydrochlorothiazide. 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 Moduretic 5-50 is amiloride and hydrochlorothiazide. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Moduretic 5-50 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 5MG ANHYDROUS;50MG | Discontinued | None | 2 | AB |
NDA 018201, held by MERCK RESEARCH LABORATORIES DIV MERCK CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic amiloride and hydrochlorothiazide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 071111 | AB (A-rated, therapeutically equivalent) | May 10, 1988 | EQ 5MG ANHYDROUS;50MG |
| RISING PHARMA HOLDING INC | 073209 | AB (A-rated, therapeutically equivalent) | October 31, 1991 | EQ 5MG ANHYDROUS;50MG |
Questions
Is there a generic for Moduretic 5-50?
Yes. The generic name for Moduretic 5-50 is amiloride and hydrochlorothiazide. 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 Moduretic 5-50?
The active ingredient in Moduretic 5-50 is amiloride and hydrochlorothiazide, 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.