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

c4d66e80-f0bc-4e64-a0f0-630ef673da1b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 6, 2023

Manufacturers

FDA

Par Pharmaceutical, Inc.

DUNS: 092733690

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 Code49884-151

Application NumberANDA205770

Product Classification

Marketing Category

C73584

Generic Name

Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateMarch 15, 2023

FDA Product Classification

INGREDIENTS (21)

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

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

LECITHIN, SOYBEANInactive

Code: 1DI56QDM62

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32I

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UI

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

XANTHAN GUMInactive

Code: TTV12P4NEE

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

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Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride

Products 1

Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

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Company

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