FDA Orange Book
Is there a generic for Hemiclor?
Hemiclor contains chlorthalidone. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Hemiclor (chlorthalidone). The Orange Book shows its last listed patent expires September 4, 2045.
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Hemiclor products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 12.5MG | Marketed (Rx) | None | 0 | None |
NDA 218647, held by PRM PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Hemiclor patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12667554 | September 4, 2045 | Drug product | None | 218647 |
Hemiclor NDC codes
Questions
Is there a generic for Hemiclor?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Hemiclor (chlorthalidone). The Orange Book shows its last listed patent expires September 4, 2045.
What is the generic name for Hemiclor?
The active ingredient in Hemiclor is chlorthalidone, per the FDA Orange Book.
When does the Hemiclor patent expire?
The last patent listed for Hemiclor in the Orange Book expires September 4, 2045. A listed patent expiry date is not a generic launch date.
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.