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FDA Approval

Piperacillin and Tazobactam

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

FDA Approval Summary

Company
Effective Date
December 31, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Piperacillin(3 g in 15 mL)
Tazobactam(0.375 g in 15 mL)

Manufacturing Establishments1

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

Istituto Biochimico Italiano Giovanni Lorenzini

Fresenius Kabi USA, LLC

432432581

Products3

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

Piperacillin and Tazobactam

Product Details

NDC Product Code
63323-300
Application Number
ANDA065523
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
December 31, 2019
Code: M98T69Q7HPClass: ACTIMQuantity: 3 g in 15 mL
Code: UXA545ABTTClass: ACTIMQuantity: 0.375 g in 15 mL

Piperacillin and Tazobactam

Product Details

NDC Product Code
63323-320
Application Number
ANDA065523
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
December 31, 2019
Code: M98T69Q7HPClass: ACTIMQuantity: 4 g in 20 mL
Code: UXA545ABTTClass: ACTIMQuantity: 0.5 g in 20 mL

Piperacillin and Tazobactam

Product Details

NDC Product Code
63323-309
Application Number
ANDA065523
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
December 31, 2019
Code: M98T69Q7HPClass: ACTIMQuantity: 2 g in 10 mL
Code: UXA545ABTTClass: ACTIMQuantity: 0.25 g in 10 mL
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