FDA.reportPublic FDA data

QKit Procedure Tray

Product NDC
59365-9074
Requested package NDC
59365-9074-1
11-digit product format
593659074
Labeler code
59365
Product ID
59365-9074_5f205b98-6712-44e6-b986-0811f25a13f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine hydrochloride, epinephrine bitartrate, ferric subsulfate aqueous, iodine and potassium iodide
Dosage form
KIT
Labeler
CooperSurgical, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-05-31
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59365-907459365-9074-1IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59365-9074-12023-01-30C16284748780-19d75b9d0-fd12-f424-e053-dadaa90a57ceQKit
59365-9074-12020-04-15C16284748780-19d75b9d0-fd12-f424-e053-dadaa90a57ceQKit
59365-9074-12020-01-31C16284748780-19d75b9d0-fd12-f424-e053-dadaa90a57ceQKit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59365-9074-1QKit Procedure Tray1 in 1 PACKAGEKIT12
59365-9074-1QKit Procedure Tray5 in 1 PACKAGEKIT52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59365-9074QKIT PROCEDURE TRAY (LIDOCAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE, FERRIC SUBSULFATE AQUEOUS, IODINE AND POTASSIUM IODIDE) KIT [COOPERSURGICAL, INC.]2Legacy NDC, 2 package rows20200416_6d061538-7a4e-4af2-a4a6-a9b010c092f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
544860ferric subsulfate 259 MG/GM Topical SolutionPSN6d061538-7a4e-4af2-a4a6-a9b010c092f62
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSN6d061538-7a4e-4af2-a4a6-a9b010c092f62
1010755Xylocaine 1 % / EPINEPHrine 1:100,000 Injectable SolutionPSN6d061538-7a4e-4af2-a4a6-a9b010c092f62
1010755epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable Solution [Xylocaine with Epinephrine]SBD6d061538-7a4e-4af2-a4a6-a9b010c092f62
1010751epinephrine 0.01 MG/ML / lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD6d061538-7a4e-4af2-a4a6-a9b010c092f62
544860ferric subsulfate solution 259 MG/ML Topical SolutionSCD6d061538-7a4e-4af2-a4a6-a9b010c092f62
1010751epinephrine (as epinephrine bitartrate) 1:100,000 / lidocaine hydrochloride 1 % Injectable SolutionSY6d061538-7a4e-4af2-a4a6-a9b010c092f62
1010751lidocaine HCl 1 % / EPINEPHrine 1:100,000 Injectable SolutionSY6d061538-7a4e-4af2-a4a6-a9b010c092f62
1010755Xylocaine 1 % with epinephrine 1:100,000 Injectable SolutionSY6d061538-7a4e-4af2-a4a6-a9b010c092f62
1010755Xylocaine with Epinephrine 1/1:100,000 (lidocaine hydrochloride / epinephrine (as epinephrine bitartrate) ) Injectable SolutionSY6d061538-7a4e-4af2-a4a6-a9b010c092f62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59365-9074-1593659074015 PACKAGE in 1 PACKAGE (59365-9074-1) > 1 KIT in 1 PACKAGE * 8 mL in 1 VIAL, SINGLE-USE * 8 g in 1 VIAL, SINGLE-USE * 10 mL in 1 VIAL, MULTI-DOSE5 package2015-05-310000-00-00NoNoCurrent