Pylera
These highlights do not include all the information needed to use PYLERA safely and effectively. See full prescribing information for PYLERA. Initial U.S. Approval: 2006
Approved
Approval ID
7fe5d2db-c59d-4e15-acd7-f9df8eca45aa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 3, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 (140 mg/125 mg/125 mg)
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6151
Application NumberNDA050786
Product Classification
M
Marketing Category
C73594
G
Generic Name
Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride (140 mg/125 mg/125 mg)
Product Specifications
Route of AdministrationORAL
Effective DateMarch 14, 2011
FDA Product Classification
INGREDIENTS (8)
MetronidazoleActive
Quantity: 125 mg in 1 1
Code: 140QMO216E
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Bismuth subcitrate potassiumActive
Quantity: 140 mg in 1 1
Code: R3O80H60KX
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Tetracycline hydrochlorideActive
Quantity: 125 mg in 1 1
Code: P6R62377KV
Classification: ACTIB