Medicine
Bismuth subcitrate, Metronidazole and Tetracycline 140 mg/125 mg/125 mg capsule
Bismuth subcitrate, Metronidazole and Tetracycline 140 mg/125 mg/125 mg capsule is a generic prescription medicine for oral use, made by 3 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at controlled room temperature of 20°C to 25°C (68°F to 77°F).
Key facts
- Active ingredient (INN)
- Bismuth subcitrate, Metronidazole and Tetracycline
- Brand
- Sold under the generic name
- Strength
- 140 mg/125 mg/125 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 10 blister pack, 120 capsules
- Manufacturers
- H2-PharmaIngenus PharmaceuticalsPar Health
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature of 20°C to 25°C (68°F to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A02BD08 Bismuth subcitrate, Metronidazole and Tetracycline
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 March 2023
- Identifiers
- RxCUI 1294619DailyMed set ID c29bfde9-5eb4-422a-bd30-4bce45e73dc0, c4d66e80-f0bc-4e64-a0f0-630ef673da1b, 4c7f024d-ba26-43cf-a36f-597e2168cd9fNDC 61269-386, 49884-151, 50742-283Application NDA050786, ANDA205770, ANDA217511
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 blister pack in 1 box / 12 capsule in 1 blister pack | 61269-386-12 | H2-Pharma | 1 July 2025 |
| 120 capsule in 1 carton | 50742-283-13 | Ingenus Pharmaceuticals | 4 July 2023 |
| 120 capsule in 1 carton | 49884-151-54 | Par Health | 7 March 2023 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 28 September 2006 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Bismuth subcitrate, Metronidazole and Tetracycline 140 mg/125 mg/125 mg capsule.
Clinical summary
Bismuth subcitrate, Metronidazole and Tetracycline is a fixed-dose combination of a bismuth, a nitroimidazole antimicrobial and a tetracycline-class antimicrobial indicated , in combination with omeprazole, among other approved uses. MedsAcross supplies Bismuth subcitrate, Metronidazole and Tetracycline for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Bismuth subcitrate, Metronidazole and TetracyclineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- PYLERA prescribing information (H2-Pharma) · U.S. National Library of Medicine, DailyMed
Need Bismuth subcitrate, Metronidazole and Tetracycline 140 mg/125 mg/125 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.