FDA Orange Book
Generic for Diuril
Diuril contains chlorothiazide. 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 Diuril is chlorothiazide. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 4 Diuril products the Orange Book lists.
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Diuril products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 500MG BASE/VIAL | Discontinued | None | 5 | AP |
| suspension, oral | 250MG/5ML | Discontinued | None | 0 | None |
| tablet, oral | 250MG | Discontinued | None | 0 | None |
| tablet, oral | 500MG | Discontinued | None | 0 | None |
NDA 011145, 011870, held by RISING PHARMA HOLDINGS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic chlorothiazide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 090896 | AP (A-rated, therapeutically equivalent) | October 16, 2009 | EQ 500MG BASE/VIAL |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 091546 | AP (A-rated, therapeutically equivalent) | July 26, 2011 | EQ 500MG BASE/VIAL |
| AMERICAN REGENT INC | 202561 | AP (A-rated, therapeutically equivalent) | April 22, 2013 | EQ 500MG BASE/VIAL |
| SAGENT PHARMACEUTICALS INC | 202462 | AP (A-rated, therapeutically equivalent) | May 29, 2015 | EQ 500MG BASE/VIAL |
| GLAND PHARMA LTD | 218630 | AP (A-rated, therapeutically equivalent) | October 3, 2024 | EQ 500MG BASE/VIAL |
Diuril NDC codes
Questions
Is there a generic for Diuril?
Yes. The generic name for Diuril is chlorothiazide. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 4 Diuril products the Orange Book lists.
What is the generic name for Diuril?
The active ingredient in Diuril is chlorothiazide, 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.