FDA Orange Book
Generic for Lopressor HCT
Lopressor HCT contains metoprolol 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 Lopressor HCT is metoprolol and hydrochlorothiazide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Lopressor HCT products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 25MG;100MG | Discontinued | None | 3 | AB |
| tablet, oral | 25MG;50MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 50MG;100MG | Discontinued | None | 2 | AB |
NDA 018303, held by VALIDUS PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic metoprolol and hydrochlorothiazide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS | 076792 | AB (A-rated, therapeutically equivalent) | August 20, 2004 | 25MG;100MG, 25MG;50MG, 50MG;100MG |
| ALEMBIC PHARMACEUTICALS LTD | 202870 | AB (A-rated, therapeutically equivalent) | November 6, 2013 | 25MG;100MG, 25MG;50MG, 50MG;100MG |
| PHARMAZONE | 215789 | AB (A-rated, therapeutically equivalent) | January 8, 2025 | 25MG;100MG, 25MG;50MG |
Questions
Is there a generic for Lopressor HCT?
Yes. The generic name for Lopressor HCT is metoprolol and hydrochlorothiazide. 3 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 Lopressor HCT?
The active ingredient in Lopressor HCT is metoprolol 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.