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
5cdacbf5-67be-42eb-bd54-8acc32ea1abc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 19, 2023
Manufacturers
FDA
H2-Pharma, LLC
DUNS: 028473634
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, and TETRACYCLINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61269-380
Application NumberNDA050786
Product Classification
M
Marketing Category
C73594
G
Generic Name
BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, and TETRACYCLINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 19, 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
TETRACYCLINE HYDROCHLORIDEActive
Quantity: 125 mg in 1 1
Code: P6R62377KV
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT