FDA Orange Book
Generic for Helidac
Helidac contains bismuth subsalicylate, metronidazole and tetracycline. 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 Helidac is bismuth subsalicylate, metronidazole and tetracycline. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Helidac products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, chewable, tablet, capsule, oral | 262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG | Discontinued | None | 1 | None |
NDA 050719, held by CASPER PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bismuth subsalicylate, metronidazole and tetracycline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AILEX PHARMACEUTICALS LLC | 202584 | None (No TE code listed) | November 30, 2018 | 262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG |
Questions
Is there a generic for Helidac?
Yes. The generic name for Helidac is bismuth subsalicylate, metronidazole and tetracycline. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Helidac?
The active ingredient in Helidac is bismuth subsalicylate, metronidazole and tetracycline, 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.