Piperacillin and Tazobactam

Product NDC
63323-304
11-digit product format
633230304
Labeler code
63323
Product ID
63323-304_46a8c499-9f29-471c-9ace-ba0bb9780ad8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin Sodium and Tazobactam Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA090498
Marketing category
ANDA
Marketing start
2011-05-31
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
36; 4.5 g/180mL; g/180mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Piperacillin and Tazobactam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIPERACILLIN SODIUM36 g/180mL
TAZOBACTAM SODIUM4.5 g/180mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM98T69Q7HP, UXA545ABTT
Rxcui312447

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5fa255cf-091e-4504-8ebf-eef4259776e8Product name120260112
a6bfe911-d09e-4049-bcde-a3213184a72cProduct name820240501
61877847-a958-4874-a7cf-2bbeff51a37bProduct name220180717
e0d9b1cf-1fe5-42a8-b30f-70b3a7bd8d22Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-304-74Piperacillin and Tazobactam180 mL in 1 BOTTLEINJECTION, POWDER, FOR SOLUTION1808
63323-304-74Piperacillin and Tazobactam1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION18
63323-304-78Piperacillin and Tazobactam1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14
63323-304-78Piperacillin and Tazobactam180 mL in 1 BOTTLEINJECTION, POWDER, FOR SOLUTION1804
63323-304-94Piperacillin and Tazobactam1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14
63323-304-94Piperacillin and Tazobactam180 mL in 1 BOTTLEINJECTION, POWDER, FOR SOLUTION1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-304-74EA - Each63323-3042b8f5210-2386-47b8-845b-c304201391f112012-07-24
63323-304-78EA - Each63323-304bc3b0dcd-f60b-475b-856e-630ba42715a912015-07-20
63323-304-94EA - Each63323-3048006ab8d-ea67-4076-82f2-f4507f23c3e212015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIPERACILLIN SODIUMACTIVE INGREDIENTM98T69Q7HPPIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
TAZOBACTAM SODIUMACTIVE INGREDIENTUXA545ABTTPIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
PIPERACILLIN ANHYDROUSACTIVE MOIETY9I628532GXPIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
TAZOBACTAMACTIVE MOIETYSE10G96M8WPIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4
PIPERACILLIN SODIUMACTIVE INGREDIENTM98T69Q7HPPIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
PIPERACILLIN SODIUMACTIVE INGREDIENTM98T69Q7HPPIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
TAZOBACTAM SODIUMACTIVE INGREDIENTUXA545ABTTPIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
TAZOBACTAM SODIUMACTIVE INGREDIENTUXA545ABTTPIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
PIPERACILLIN ANHYDROUSACTIVE MOIETY9I628532GXPIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
PIPERACILLIN ANHYDROUSACTIVE MOIETY9I628532GXPIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
TAZOBACTAMACTIVE MOIETYSE10G96M8WPIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
TAZOBACTAMACTIVE MOIETYSE10G96M8WPIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-304PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]8Current NDC, Legacy NDC, 2 package rows20241023_c78e0931-ec79-58e5-8658-7fe692dc3b8b.zip
63323-304PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20241023_2cfa6723-175b-4c4d-8212-266844b07610.zip
63323-304PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20241023_e53ebafc-3afa-4a1e-9313-fecd1c1c5d7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSNc78e0931-ec79-58e5-8658-7fe692dc3b8b8
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCDc78e0931-ec79-58e5-8658-7fe692dc3b8b8
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSYc78e0931-ec79-58e5-8658-7fe692dc3b8b8
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSN2cfa6723-175b-4c4d-8212-266844b076104
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSNe53ebafc-3afa-4a1e-9313-fecd1c1c5d7c4
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCD2cfa6723-175b-4c4d-8212-266844b076104
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCDe53ebafc-3afa-4a1e-9313-fecd1c1c5d7c4
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSY2cfa6723-175b-4c4d-8212-266844b076104
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSYe53ebafc-3afa-4a1e-9313-fecd1c1c5d7c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-304-74633230304741 BOTTLE in 1 CARTON (63323-304-74) / 180 mL in 1 BOTTLE1 bottle2011-05-310000-00-00NoNoCurrent
63323-304-78633230304781 BOTTLE in 1 CARTON (63323-304-78) / 180 mL in 1 BOTTLE1 bottle2011-05-310000-00-00NoNoCurrent
63323-304-94633230304941 BOTTLE in 1 CARTON (63323-304-94) / 180 mL in 1 BOTTLE1 bottle2011-05-310000-00-00NoNoCurrent