Piperacillin and Tazobactam

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 013547657

Effective Date

May 19, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Piperacillin(4 g in 20 mL)

Tazobactam(0.5 g in 20 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Fresenius Kabi USA, LLC

DUNS Number

438137085

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

65219-259

Application Number

ANDA203719

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS

Effective Date

May 19, 2021

Ingredients

Code: M98T69Q7HPClass: ACTIMQuantity: 4 g in 20 mL

Code: UXA545ABTTClass: ACTIMQuantity: 0.5 g in 20 mL