Indocyanine green

Product NDC
75874-424
11-digit product format
758740424
Labeler code
75874
Product ID
75874-424_6e73b170-b84e-4e37-ac0f-7ba7f60c057f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indocyanine green
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Novadaq Technologies Inc.
Application
ANDA040811
Marketing category
ANDA
Marketing start
2011-12-01
Marketing end
0000-00-00
Substance
INDOCYANINE GREEN
Active strength
25 mg/1
Pharmacologic classes
Diagnostic Dye [EPC],Dyes [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
75874-424-012019-11-13C16284748780-197449f38-b6e7-f6ea-e053-dbdaa90aa703Indocyanine Green for Injection USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75874-424-01Indocyanine green1 in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,11
75874-424-01Indocyanine green1 in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,125 mg1

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75874-424INDOCYANINE GREEN KIT INDOCYANINE GREEN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADAQ TECHNOLOGIES INC.]1Legacy NDC, 1 package rows20111201_c1031b17-b6e3-4153-869f-30d9c7e66bc3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
75874-424-01758740424011 in 1 VIAL, GLASSHistorical