Pylera
These 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: 2006
Approved
Approval ID
a762e164-b390-4e8c-bd46-bf6c31eeb486
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2021
Manufacturers
FDA
Allergan, Inc.
DUNS: 144796497
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58914-601
Application NumberNDA050786
Product Classification
M
Marketing Category
C73594
G
Generic Name
Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2023
FDA Product Classification
INGREDIENTS (8)
BISMUTH SUBCITRATE POTASSIUMActive
Quantity: 140 mg in 1 1
Code: R3O80H60KX
Classification: ACTIB
METRONIDAZOLEActive
Quantity: 125 mg in 1 1
Code: 140QMO216E
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TETRACYCLINE HYDROCHLORIDEActive
Quantity: 125 mg in 1 1
Code: P6R62377KV
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT