FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
68001-507
11-digit product format
680010507
Labeler code
68001
Product ID
68001-507_3774b148-777d-9de2-e063-6394a90a5245
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIPERACILLIN and TAZOBACTAM
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA204959
Marketing category
ANDA
Marketing start
2021-08-11
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
68001-507-53Piperacillin and Tazobactam15 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION158
68001-507-82Piperacillin and Tazobactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-507-53EA - Each68001-5076d95ff0b-77ab-437c-9831-de639e57ea4c12021-09-07
68001-507-82EA - Each68001-5070121a59f-db08-4ea3-a1ca-b34cd3e298ed12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-507PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [BLUEPOINT LABORATORIES]7Current NDC, Legacy NDC, 2 package rows20241115_1aba753c-d0c2-4b35-917a-9143dd4be468.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659131piperacillin / tazobactam 2.25 GM InjectionPSN1aba753c-d0c2-4b35-917a-9143dd4be4688
1659137piperacillin / tazobactam 3.375 GM InjectionPSN1aba753c-d0c2-4b35-917a-9143dd4be4688
1659149piperacillin / tazobactam 4.5 GM InjectionPSN1aba753c-d0c2-4b35-917a-9143dd4be4688
1659131piperacillin 2000 MG / tazobactam 250 MG InjectionSCD1aba753c-d0c2-4b35-917a-9143dd4be4688
1659137piperacillin 3000 MG / tazobactam 375 MG InjectionSCD1aba753c-d0c2-4b35-917a-9143dd4be4688
1659149piperacillin 4000 MG / tazobactam 500 MG InjectionSCD1aba753c-d0c2-4b35-917a-9143dd4be4688
1659131piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG InjectionSY1aba753c-d0c2-4b35-917a-9143dd4be4688
1659137piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG InjectionSY1aba753c-d0c2-4b35-917a-9143dd4be4688
1659149piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG InjectionSY1aba753c-d0c2-4b35-917a-9143dd4be4688
1659131piperacillin / tazobactam 2.25 GM InjectionSY1aba753c-d0c2-4b35-917a-9143dd4be4688
1659137piperacillin / tazobactam 3.375 GM InjectionSY1aba753c-d0c2-4b35-917a-9143dd4be4688
1659149piperacillin / tazobactam 4.5 GM InjectionSY1aba753c-d0c2-4b35-917a-9143dd4be4688

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-507-536800105075315 mL in 1 VIAL, SINGLE-DOSE15 mlHistorical
68001-507-826800105078210 VIAL, SINGLE-DOSE in 1 CARTON (68001-507-82) / 15 mL in 1 VIAL, SINGLE-DOSE (68001-507-53) 2021-08-110000-00-00NoNoCurrent