BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE
These highlights do not include all the information needed to use BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE CAPSULES. BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE and TETRACYCLINE HYDROCHLORIDE CAPSULES, for oral use Initial U.S. Approval: 2006
Approved
Approval ID
c07e32ee-cd99-405d-b5e2-927d9cb204ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 7, 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
NDC Product Code61269-385
Application NumberNDA050786
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMay 31, 2023
Generic NameBISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDE
INGREDIENTS (8)
METRONIDAZOLEActive
Quantity: 125 mg in 1 1
Code: 140QMO216E
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
BISMUTH SUBCITRATE POTASSIUMActive
Quantity: 140 mg in 1 1
Code: R3O80H60KX
Classification: ACTIB
TETRACYCLINE HYDROCHLORIDEActive
Quantity: 125 mg in 1 1
Code: P6R62377KV
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT