FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
81284-155
11-digit product format
812840155
Labeler code
81284
Product ID
81284-155_1c01a9c8-0256-4129-adc7-38d1f3cf2183
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin sodium and Tazobactam sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Provepharm Inc.
Application
ANDA207848
Marketing category
ANDA
Marketing start
2019-08-01
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
UniiUXA545ABTT, M98T69Q7HP
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
81284-155-00Piperacillin and Tazobactam180 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, LYOPHILIZED,1807
81284-155-01Piperacillin and Tazobactam1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81284-155-00EA - Each81284-155af9bc56c-3475-4b80-8775-92a3c493f87412023-09-05
81284-155-01EA - Each81284-155e8678392-64a8-4ccc-aa76-d5edc5caa96512022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81284-155PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PROVEPHARM INC.]7Current NDC, Legacy NDC, 2 package rows20250305_68d5384d-1691-4afc-8a1a-488f8e2ef2c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSN68d5384d-1691-4afc-8a1a-488f8e2ef2c57
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCD68d5384d-1691-4afc-8a1a-488f8e2ef2c57
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSY68d5384d-1691-4afc-8a1a-488f8e2ef2c57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81284-155-0081284015500180 mL in 1 VIAL, PHARMACY BULK PACKAGE180 mlHistorical
81284-155-01812840155011 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (81284-155-01) / 180 mL in 1 VIAL, PHARMACY BULK PACKAGE (81284-155-00) 2019-08-010000-00-00NoNoCurrent