FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
63323-983
11-digit product format
633230983
Labeler code
63323
Product ID
63323-983_0802b499-4d2a-43ad-8fea-ad80b6738a46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin and Tazobactam
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA203719
Marketing category
ANDA
Marketing start
2018-05-18
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
3; .375 g/15mL; g/15mL
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 SODIUM3 g/15mL
TAZOBACTAM SODIUM.375 g/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM98T69Q7HP, UXA545ABTT
Rxcui1659131, 1659137, 1659149

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
63323-983-21Piperacillin and Tazobactam10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,106
63323-983-23Piperacillin and Tazobactam15 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,156
63323-983-41Piperacillin and Tazobactam15 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,154
63323-983-53Piperacillin and Tazobactam10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-983-21EA - Each63323-983ae777587-341b-4ddd-9597-987ad8c8803912019-08-06
63323-983-23EA - Each63323-9834f6bdde7-be64-4c2a-b03c-f8f5b70cd64712019-08-06
63323-983-41EA - Each63323-983ae1b80e7-2ffc-4c8c-89f0-8a197958d7ee12019-10-07
63323-983-53EA - Each63323-98375fe8371-7d0c-4c38-ab18-3f2c47c7c39f12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-983PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 2 package rows20221104_dc8208ea-a632-4291-a90b-2eba9a33bb40.zip
63323-983PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC, 2 package rows20221029_1eb40c84-0cb3-4648-a39f-f4ebc4dbcb16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659131piperacillin / tazobactam 2.25 GM InjectionPSNdc8208ea-a632-4291-a90b-2eba9a33bb406
1659137piperacillin / tazobactam 3.375 GM InjectionPSNdc8208ea-a632-4291-a90b-2eba9a33bb406
1659149piperacillin / tazobactam 4.5 GM InjectionPSNdc8208ea-a632-4291-a90b-2eba9a33bb406
1659131piperacillin 2000 MG / tazobactam 250 MG InjectionSCDdc8208ea-a632-4291-a90b-2eba9a33bb406
1659137piperacillin 3000 MG / tazobactam 375 MG InjectionSCDdc8208ea-a632-4291-a90b-2eba9a33bb406
1659149piperacillin 4000 MG / tazobactam 500 MG InjectionSCDdc8208ea-a632-4291-a90b-2eba9a33bb406
1659131piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG InjectionSYdc8208ea-a632-4291-a90b-2eba9a33bb406
1659137piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG InjectionSYdc8208ea-a632-4291-a90b-2eba9a33bb406
1659149piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG InjectionSYdc8208ea-a632-4291-a90b-2eba9a33bb406
1659131piperacillin / tazobactam 2.25 GM InjectionSYdc8208ea-a632-4291-a90b-2eba9a33bb406
1659137piperacillin / tazobactam 3.375 GM InjectionSYdc8208ea-a632-4291-a90b-2eba9a33bb406
1659149piperacillin / tazobactam 4.5 GM InjectionSYdc8208ea-a632-4291-a90b-2eba9a33bb406
1659131piperacillin / tazobactam 2.25 GM InjectionPSN1eb40c84-0cb3-4648-a39f-f4ebc4dbcb164
1659137piperacillin / tazobactam 3.375 GM InjectionPSN1eb40c84-0cb3-4648-a39f-f4ebc4dbcb164
1659149piperacillin / tazobactam 4.5 GM InjectionPSN1eb40c84-0cb3-4648-a39f-f4ebc4dbcb164
1659131piperacillin 2000 MG / tazobactam 250 MG InjectionSCD1eb40c84-0cb3-4648-a39f-f4ebc4dbcb164
1659137piperacillin 3000 MG / tazobactam 375 MG InjectionSCD1eb40c84-0cb3-4648-a39f-f4ebc4dbcb164
1659149piperacillin 4000 MG / tazobactam 500 MG InjectionSCD1eb40c84-0cb3-4648-a39f-f4ebc4dbcb164
1659131piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG InjectionSY1eb40c84-0cb3-4648-a39f-f4ebc4dbcb164
1659137piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG InjectionSY1eb40c84-0cb3-4648-a39f-f4ebc4dbcb164
1659149piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG InjectionSY1eb40c84-0cb3-4648-a39f-f4ebc4dbcb164
1659131piperacillin / tazobactam 2.25 GM InjectionSY1eb40c84-0cb3-4648-a39f-f4ebc4dbcb164
1659137piperacillin / tazobactam 3.375 GM InjectionSY1eb40c84-0cb3-4648-a39f-f4ebc4dbcb164
1659149piperacillin / tazobactam 4.5 GM InjectionSY1eb40c84-0cb3-4648-a39f-f4ebc4dbcb164

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-983-216332309832110 VIAL, SINGLE-USE in 1 CARTON (63323-983-21) / 15 mL in 1 VIAL, SINGLE-USE (63323-983-23) 2018-05-180000-00-00NoNoCurrent
63323-983-236332309832315 mL in 1 VIAL, SINGLE-USE15 mlHistorical
63323-983-416332309834115 mL in 1 VIAL, SINGLE-USE15 mlHistorical
63323-983-536332309835310 VIAL, SINGLE-USE in 1 CARTON (63323-983-53) / 15 mL in 1 VIAL, SINGLE-USE (63323-983-41) 2018-05-180000-00-00NoNoCurrent