Leep RediKit

Product NDC: 59365-6061
Requested package NDC: 59365-6061-1
11-digit product format: 593656061
Labeler code: 59365
Product ID: 59365-6061_a72a696b-020b-4f88-a498-f2a8b9442677
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mepivacaine hydrochloride, lidocaine hydrochloride, epinephrine bitartrate, iodine, potassium iodide, ferric subsulfate
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59365-6061	59365-6061-1	D	Discontinued by firm		2026-10-05

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

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59365-6061	LEEP REDIKIT (MEPIVACAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE, IODINE, POTASSIUM IODIDE, FERRIC SUBSULFATE) KIT [COOPERSURGICAL, INC.]	5	Legacy NDC	20231102_37f4ce91-7546-4502-8298-1e1210e99461.zip

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59365-6061-1	59365606101	1 KIT in 1 PACKAGE (59365-6061-1) * 8 mL in 1 VIAL, SINGLE-USE * 8 g in 1 VIAL, SINGLE-USE * 10 mL in 1 VIAL, MULTI-DOSE	1 kit	2015-05-31	0000-00-00	No	No	Current