FDA.reportPublic FDA data

Piperacillin and Tazobactam

Product NDC
60505-6157
Requested package NDC
60505-6157-4
11-digit product format
605056157
Labeler code
60505
Product ID
60505-6157_0702bfe3-61ba-4c3e-a9e4-ceafca2a8821
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIPERACILLIN and TAZOBACTAM
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA204959
Marketing category
ANDA
Marketing start
2019-03-15
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

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204959-001PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10
A204959-002PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10
A204959-003PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A204959-001AP
A204959-002AP
A204959-003AP

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 22:54:322026-06A204959-001PIPERACILLIN AND TAZOBACTAMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10a50c72e98297…
2026-08-01 22:54:322026-06A204959-002PIPERACILLIN AND TAZOBACTAMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10a50c72e98297…
2026-08-01 22:54:322026-06A204959-003PIPERACILLIN AND TAZOBACTAMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2018-08-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204959-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A204959-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A204959-003AP1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMBluePoint Laboratories1aba753c-d0c2-4b35-917a-9143dd4be4682025-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204959
application number: ANDA204959
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMApotex Corp.2c8f06a2-49b2-4169-94ef-182d13d248bf2025-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204959
application number: ANDA204959
ndc (package): 60505-6157-4
ndc (product): 60505-6157
ndc11 (package): 60505615704
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMShandong Anxin Pharmaceutical Co., Ltd.420196a5-f62d-473f-84d8-d7fc3f31c3d32024-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204959
application number: ANDA204959

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1659131Internal RxNorm lookup
1659137Internal RxNorm lookup
1659149Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2c8f06a2-49b2-4169-94ef-182d13d248bfAvailable 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
60505-6157-0Piperacillin and Tazobactam15 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION1512
60505-6157-4Piperacillin and Tazobactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6157-0EA - Each60505-6157afe98ee6-f4c7-46a1-84c4-ea5eb01334ae12019-03-12
60505-6157-4EA - Each60505-61573530be59-0dfb-4760-8a91-61ace9cc632512019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6157PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, FOR SOLUTION [APOTEX CORP.]12Current NDC, Legacy NDC, 2 package rows20250523_2c8f06a2-49b2-4169-94ef-182d13d248bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659131piperacillin / tazobactam 2.25 GM InjectionPSN2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659137piperacillin / tazobactam 3.375 GM InjectionPSN2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659149piperacillin / tazobactam 4.5 GM InjectionPSN2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659131piperacillin 2000 MG / tazobactam 250 MG InjectionSCD2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659137piperacillin 3000 MG / tazobactam 375 MG InjectionSCD2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659149piperacillin 4000 MG / tazobactam 500 MG InjectionSCD2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659131piperacillin (as piperacillin sodium) 2000 MG / tazobactam (as tazobactam sodium) 250 MG InjectionSY2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659137piperacillin (as piperacillin sodium) 3000 MG / tazobactam (as tazobactam sodium) 375 MG InjectionSY2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659149piperacillin (as piperacillin sodium) 4000 MG / tazobactam (as tazobactam sodium) 500 MG InjectionSY2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659131piperacillin / tazobactam 2.25 GM InjectionSY2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659137piperacillin / tazobactam 3.375 GM InjectionSY2c8f06a2-49b2-4169-94ef-182d13d248bf12
1659149piperacillin / tazobactam 4.5 GM InjectionSY2c8f06a2-49b2-4169-94ef-182d13d248bf12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-6157-46050561570410 VIAL, SINGLE-DOSE in 1 CARTON (60505-6157-4) / 15 mL in 1 VIAL, SINGLE-DOSE (60505-6157-0) 2019-03-150000-00-00NoNoCurrent