FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
60505-6262
Requested package NDC
60505-6262-0
11-digit product format
605056262
Labeler code
60505
Product ID
60505-6262_36e76c91-4d5f-402d-addd-eef8d5cef887
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Piperacillin and Tazobactam
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA217243
Marketing category
ANDA
Marketing start
2023-09-26
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217243-001PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2023-04-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A217243-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A217243-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2023-04-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A217243-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMApotex Corp.c18109cf-d5db-4cc1-83da-537c8ab0e05c2024-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217243
application number: ANDA217243
ndc (package): 60505-6262-0
ndc (product): 60505-6262
ndc11 (package): 60505626200
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMShandong Anxin Pharmaceutical Co., Ltd.f817b9be-b12b-48ac-8e4e-57ef6812eb322024-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217243
application number: ANDA217243

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
UXA545ABTTInternal UNII lookup
M98T69Q7HPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312447Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c18109cf-d5db-4cc1-83da-537c8ab0e05cAvailable on FDA.report

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
60505-6262-0Piperacillin and Tazobactam180 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, LYOPHILIZED,1804
60505-6262-0Piperacillin and Tazobactam1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6262-0EA - Each60505-6262156a19a6-4f64-4f9c-960f-1260055c211012023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6262PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APOTEX CORP.]4Current NDC, 2 package rows20241015_c18109cf-d5db-4cc1-83da-537c8ab0e05c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionPSNc18109cf-d5db-4cc1-83da-537c8ab0e05c4
312447piperacillin 200 MG/ML / tazobactam 25 MG/ML Injectable SolutionSCDc18109cf-d5db-4cc1-83da-537c8ab0e05c4
312447piperacillin (as piperacillin sodium) 200 MG/ML / tazobactam (as tazobactam sodium) 25 MG/ML Injectable SolutionSYc18109cf-d5db-4cc1-83da-537c8ab0e05c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60505-6262-0605056262001 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (60505-6262-0) / 180 mL in 1 VIAL, PHARMACY BULK PACKAGE2023-09-26NoNoCurrent