Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Steriscience Pte. Limited
659844097
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Steriscience Specialties Private Limited
Steriscience Specialties Private Limited
Steriscience Pte. Limited
650391548
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
82449-500Application Number
ANDA065458Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
July 5, 2023PiperacillinActive
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
82449-502Application Number
ANDA065458Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
July 5, 2023PiperacillinActive
Code: M98T69Q7HPClass: ACTIMQuantity: 4 g in 20 mL
TazobactamActive
Code: UXA545ABTTClass: ACTIMQuantity: 0.5 g in 20 mL
piperacillin and tazobactam
Product Details
NDC Product Code
82449-501Application Number
ANDA065458Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
July 5, 2023PiperacillinActive
Code: M98T69Q7HPClass: ACTIMQuantity: 3 g in 15 mL
TazobactamActive
Code: UXA545ABTTClass: ACTIMQuantity: 0.375 g in 15 mL