Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Haupt Pharma Latina S.r.l.
Fresenius Kabi USA, LLC
338690598
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
63323-983Application Number
ANDA203719Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
January 23, 2020PiperacillinActive
Code: M98T69Q7HPClass: ACTIMQuantity: 3 g in 15 mL
TazobactamActive
Code: UXA545ABTTClass: ACTIMQuantity: 0.375 g in 15 mL
Piperacillin and Tazobactam
Product Details
NDC Product Code
63323-981Application Number
ANDA203719Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
January 23, 2020PiperacillinActive
Code: M98T69Q7HPClass: ACTIMQuantity: 2 g in 10 mL
TazobactamActive
Code: UXA545ABTTClass: ACTIMQuantity: 0.25 g in 10 mL
Piperacillin and Tazobactam
Product Details
NDC Product Code
63323-982Application Number
ANDA203719Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
January 23, 2020PiperacillinActive
Code: M98T69Q7HPClass: ACTIMQuantity: 4 g in 20 mL
TazobactamActive
Code: UXA545ABTTClass: ACTIMQuantity: 0.5 g in 20 mL