FDA.reportPublic FDA data

SPY-MIS Kit

Product NDC
66259-936
11-digit product format
662590936
Labeler code
66259
Product ID
66259-936_6f8cce61-6751-4924-a7f0-c90d532a9002
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
indocyanine green
Dosage form
KIT
Route
INTRAVASCULAR; INTRAVENOUS
Labeler
Novadaq Technologies Inc
Application
NDA211580
Marketing category
NDA
Marketing start
2019-09-10
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e86469f1-0431-b4e2-fe09-0dbe527624d7Product name220250804
e4138432-bbdb-43bd-8e68-9964f0048734Product name120190228

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66259-936-152025-01-30C16284748780-12cef2736-a32d-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use SPY AGENT GREEN safely and effectively. See full prescribing information for SPY AGENT GREEN. SPY AGENT ® GREEN (indocyanine green for injection), for intravenous, interstitial, or intradermal use Initial U.S. Approval: 1959
66259-936-252025-01-30C16284748780-12cef2736-a32d-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use SPY AGENT GREEN safely and effectively. See full prescribing information for SPY AGENT GREEN. SPY AGENT ® GREEN (indocyanine green for injection), for intravenous, interstitial, or intradermal use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66259-146-01SPY-MIS Kit1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,125 mg16
66259-146-02SPY-MIS Kit1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,25 mg16
66259-936-15SPY-MIS Kit1 in 1 KITKIT116
66259-936-25SPY-MIS Kit6 in 1 CASEKIT616
66259-936-25SPY-MIS Kit1 in 1 KITKIT116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66259-936-15EA - Each66259-936eb6f5880-de34-4b6e-84f5-31eb2cd4050312023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66259-936SPY ELITE KIT (INDOCYANINE GREEN) KIT SPY-PHI KIT (INDOCYANINE GREEN) KIT SPY-MIS KIT (INDOCYANINE GREEN) KIT SPY LYMPHATICS KIT (INDOCYANINE GREEN) KIT PINPOINT LYMPHATICS KIT (INDOCYANINE GREEN) KIT [NOVADAQ TECHNOLOGIES INC]16Legacy NDC, 5 package rows20230616_95d11200-1cca-4044-b652-82dac72103b9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66259-146-01662590146011 in 1 VIALHistorical
66259-146-02662590146021 in 1 VIALHistorical
66259-936-15662590936151 KIT in 1 KIT (66259-936-15) * 10 mL in 1 VIAL, PLASTIC * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (66259-146-01) 1 kit2019-09-100000-00-00NoNoCurrent
66259-936-25662590936256 KIT in 1 CASE (66259-936-25) > 1 KIT in 1 KIT * 10 mL in 1 VIAL, PLASTIC * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (66259-146-01) 6 kit2019-09-100000-00-00NoNoCurrent