FDA Orange Book
Generic for Pylera
Pylera contains bismuth subcitrate, 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 Pylera is bismuth subcitrate, metronidazole and tetracycline. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Pylera products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 140MG;125MG;125MG | Marketed (Rx) | AB | 2 | AB |
NDA 050786, held by LABORATOIRES JUVISE PHARMACEUTICALS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bismuth subcitrate, metronidazole and tetracycline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 205770 | AB (A-rated, therapeutically equivalent) | March 6, 2023 | 140MG;125MG;125MG |
| INGENUS PHARMACEUTICALS LLC | 217511 | AB (A-rated, therapeutically equivalent) | July 3, 2023 | 140MG;125MG;125MG |
Pylera NDC codes
Questions
Is there a generic for Pylera?
Yes. The generic name for Pylera is bismuth subcitrate, metronidazole and tetracycline. 2 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 Pylera?
The active ingredient in Pylera is bismuth subcitrate, 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.