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Bismuth subcitrate potassium, Metronidazole, 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 useInitial U.S. Approval: 2006

Approved
Approval ID

4c7f024d-ba26-43cf-a36f-597e2168cd9f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 13, 2022

Manufacturers
FDA

Ingenus Pharmaceuticals, LLC

DUNS: 833250017

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 Code50742-283
Application NumberANDA217511
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 4, 2023
FDA Product Classification

INGREDIENTS (12)

TETRACYCLINE HYDROCHLORIDEActive
Quantity: 125 mg in 1 1
Code: P6R62377KV
Classification: ACTIB
BISMUTH SUBCITRATE POTASSIUMActive
Quantity: 140 mg in 1 1
Code: R3O80H60KX
Classification: ACTIB
METRONIDAZOLEActive
Quantity: 125 mg in 1 1
Code: 140QMO216E
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT

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Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride - FDA Drug Approval Details