Isosulfan Blue

Product NDC
55150-240
11-digit product format
551500240
Labeler code
55150
Product ID
55150-240_250207b6-6225-48e8-ab86-be1a27afb182
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosulfan Blue
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eugia US LLC
Application
ANDA206831
Marketing category
ANDA
Marketing start
2016-02-02
Substance
ISOSULFAN BLUE
Active strength
50 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Isosulfan Blue
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOSULFAN BLUE50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii39N9K8S2A4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
c96fb27b-1a35-b69d-60b2-c2e272527329Product name520231206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-240-05Isosulfan Blue6 in 1 CARTONINJECTION, SOLUTION65
55150-240-05Isosulfan Blue5 mL in 1 VIALINJECTION, SOLUTION55
55150-240-06Isosulfan Blue6 in 1 CARTONINJECTION, SOLUTION63
55150-240-06Isosulfan Blue5 mL in 1 VIALINJECTION, SOLUTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-240-05ML - Milliliter55150-240a20ac464-1354-48fc-b3a2-e3ff105edf5312016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-240ISOSULFAN BLUE INJECTION, SOLUTION [EUGIA US LLC]4Current NDC, Legacy NDC, 2 package rows20240229_42f2d62a-c7f2-4706-87bc-64f3e72d63a9.zip
55150-240ISOSULFAN BLUE INJECTION, SOLUTION [EUGIA US LLC]3Current NDC, Legacy NDC, 2 package rows20241218_61b48ff8-7ace-4ab7-9f58-f250e2830d16.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-240-05551500240056 VIAL in 1 CARTON (55150-240-05) / 5 mL in 1 VIAL6 vial2016-02-020000-00-00NoNoCurrent
55150-240-06551500240066 VIAL in 1 CARTON (55150-240-06) / 5 mL in 1 VIAL6 vial2016-02-020000-00-00NoNoCurrent