FDA.reportPublic FDA data

bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG Oral Capsule [Pylera]

RxCUI
1294621
RxNorm name
bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG Oral Capsule [Pylera]
Display name
bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG Oral Capsule [Pylera]
Full name
bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG Oral Capsule [Pylera]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PYLERABISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDEH2-Pharma, LLC5cdacbf5-67be-42eb-bd54-8acc32ea1abc2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1294621
PYLERABISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDEH2-Pharma, LLCc50626a2-5969-490b-a88a-a4ee45e796152026-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1294621

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
c50626a2-5969-490b-a88a-a4ee45e79615bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG Oral Capsule [Pylera]SBD4These highlights do not include all the information needed to use PYLERA safely and effectively. See full prescribing information for PYLERA. PYLERA® (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) capsules, for oral use Initial U.S. Approval: 200620260116
c50626a2-5969-490b-a88a-a4ee45e79615Pylera (bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG) Oral CapsuleSY4These highlights do not include all the information needed to use PYLERA safely and effectively. See full prescribing information for PYLERA. PYLERA® (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) capsules, for oral use Initial U.S. Approval: 200620260116
c50626a2-5969-490b-a88a-a4ee45e79615PYLERA 140 MG / 125 MG / 125 MG Oral CapsulePSN4These highlights do not include all the information needed to use PYLERA safely and effectively. See full prescribing information for PYLERA. PYLERA® (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) capsules, for oral use Initial U.S. Approval: 200620260116
5cdacbf5-67be-42eb-bd54-8acc32ea1abcbismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG Oral Capsule [Pylera]SBD3These highlights do not include all the information needed to use PYLERA safely and effectively. See full prescribing information for PYLERA. PYLERA ® (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) capsules, for oral use Initial U.S. Approval: 200620250407
5cdacbf5-67be-42eb-bd54-8acc32ea1abcPYLERA 140 MG / 125 MG / 125 MG Oral CapsulePSN3These highlights do not include all the information needed to use PYLERA safely and effectively. See full prescribing information for PYLERA. PYLERA ® (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) capsules, for oral use Initial U.S. Approval: 200620250407
5cdacbf5-67be-42eb-bd54-8acc32ea1abcPylera (bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG) Oral CapsuleSY3These highlights do not include all the information needed to use PYLERA safely and effectively. See full prescribing information for PYLERA. PYLERA ® (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) capsules, for oral use Initial U.S. Approval: 200620250407
7fe5d2db-c59d-4e15-acd7-f9df8eca45aaPYLERA 140 MG / 125 MG / 125 MG Oral CapsulePSN1These highlights do not include all the information needed to use PYLERA safely and effectively. See full prescribing information for PYLERA. Initial U.S. Approval: 200620110203
7fe5d2db-c59d-4e15-acd7-f9df8eca45aabismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG Oral Capsule [Pylera]SBD1These highlights do not include all the information needed to use PYLERA safely and effectively. See full prescribing information for PYLERA. Initial U.S. Approval: 200620110203
7fe5d2db-c59d-4e15-acd7-f9df8eca45aaPylera (bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG) Oral CapsuleSY1These highlights do not include all the information needed to use PYLERA safely and effectively. See full prescribing information for PYLERA. Initial U.S. Approval: 200620110203