Drug
Who makes bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride?
2 companies list bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride as a human prescription drug, including under the names PYLERA. Forms: capsule. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| H2-Pharma, LLC | capsule | NDA, NDA AUTHORIZED GENERICNDA050786 | 3 | 0 |
| Par Health USA, LLCIndia | capsule | ANDAANDA205770 | 1 | 5 |
Enquiry
Common questions
- Who makes bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride?
- 2 companies list bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride as a human prescription drug in the openFDA NDC Directory, led by H2-Pharma, LLC, Par Health USA, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic PYLERA?
- 1 company lists bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.