Home NDC 60505-6262 Piperacillin and Tazobactam
Product NDC 60505-6262
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217243-001 PIPERACILLIN AND TAZOBACTAM PIPERACILLIN SODIUM; TAZOBACTAM SODIUM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217243-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217243-001 PIPERACILLIN AND TAZOBACTAM EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL INJECTABLE / INJECTION AP 2023-04-14 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Piperacillin and Tazobactam
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAZOBACTAM SODIUM 36 g/180mL PIPERACILLIN SODIUM 4.5 g/180mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination UXA545ABTT Internal UNII lookup M98T69Q7HP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312447 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-6262-0 Piperacillin and Tazobactam 180 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, POWDER, LYOPHILIZED, 180 4 60505-6262-0 Piperacillin and Tazobactam 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-6262 PIPERACILLIN AND TAZOBACTAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APOTEX CORP.] 4 Current NDC, 2 package rows 20241015_c18109cf-d5db-4cc1-83da-537c8ab0e05c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 60505-6262-0 60505626200 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (60505-6262-0) / 180 mL in 1 VIAL, PHARMACY BULK PACKAGE 2023-09-26 No No Current