FDA Orange Book
Generic for Hytrin
Hytrin contains terazosin. 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 Hytrin is terazosin. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 8 Hytrin products the Orange Book lists.
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Hytrin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 10MG BASE | Discontinued | None | 5 | AB |
| capsule, oral | EQ 1MG BASE | Discontinued | None | 5 | AB |
| capsule, oral | EQ 2MG BASE | Discontinued | None | 5 | AB |
| capsule, oral | EQ 5MG BASE | Discontinued | None | 5 | AB |
| tablet, oral | EQ 10MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 1MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 2MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 5MG BASE | Discontinued | None | 0 | None |
NDA 020347, 019057, held by ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic terazosin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PHARMAZONE | 074823 | AB (A-rated, therapeutically equivalent) | March 30, 1998 | EQ 10MG BASE, EQ 1MG BASE, EQ 2MG BASE, EQ 5MG BASE |
| BIONPHARMA INC | 075667 | AB (A-rated, therapeutically equivalent) | July 28, 2000 | EQ 10MG BASE, EQ 1MG BASE, EQ 2MG BASE, EQ 5MG BASE |
| HERITAGE PHARMA LABS INC DBA AVET PHARMACEUTICALS LABS INC | 075614 | AB (A-rated, therapeutically equivalent) | January 30, 2001 | EQ 10MG BASE, EQ 1MG BASE, EQ 2MG BASE, EQ 5MG BASE |
| JUBILANT CADISTA PHARMACEUTICALS INC | 075317 | AB (A-rated, therapeutically equivalent) | December 20, 2004 | EQ 10MG BASE, EQ 1MG BASE, EQ 2MG BASE, EQ 5MG BASE |
| AJANTA PHARMA LTD | 219482 | AB (A-rated, therapeutically equivalent) | May 12, 2025 | EQ 10MG BASE, EQ 1MG BASE, EQ 2MG BASE, EQ 5MG BASE |
Questions
Is there a generic for Hytrin?
Yes. The generic name for Hytrin is terazosin. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 8 Hytrin products the Orange Book lists.
What is the generic name for Hytrin?
The active ingredient in Hytrin is terazosin, 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.