Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochloride

Basic Information

Product Name

FDA Product Code

50742-283

Regulatory Information

NDC Product Code

50742-283

Application Number

ANDA217511

Marketing Category

C73584

Effective Date

July 4, 2023

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

TETRACYCLINE HYDROCHLORIDE

Quantity: 125 mg in 1 1

Code: P6R62377KV

Class Code: ACTIB

BISMUTH SUBCITRATE POTASSIUM

Quantity: 140 mg in 1 1

Code: R3O80H60KX

Class Code: ACTIB

METRONIDAZOLE

Quantity: 125 mg in 1 1

Code: 140QMO216E

Class Code: ACTIB

GELATIN

Code: 2G86QN327L

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

Active Moieties

BISMUTH CATION

Code: ZS9CD1I8YE

METRONIDAZOLE

Code: 140QMO216E

TETRACYCLINE

Code: F8VB5M810T

Basic Information

Regulatory Information

Company Information

Active Ingredients

GELATIN

MAGNESIUM STEARATE

LACTOSE MONOHYDRATE

TALC

TITANIUM DIOXIDE

AMMONIA

FERROSOFERRIC OXIDE

PROPYLENE GLYCOL

SHELLAC

Active Moieties

BISMUTH CATION

METRONIDAZOLE

TETRACYCLINE