Isosulfan blue

Product NDC
72205-195
11-digit product format
722050195
Labeler code
72205
Product ID
72205-195_4b7e84ee-f3ba-4b80-86d3-f4debe6a2eca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosulfan blue
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA216090
Marketing category
ANDA
Marketing start
2022-09-16
Substance
ISOSULFAN BLUE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Isosulfan blue
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOSULFAN BLUE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii39N9K8S2A4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
c96fb27b-1a35-b69d-60b2-c2e272527329Product name520231206
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-195-01Isosulfan blue1 in 1 CARTONINJECTION, SOLUTION11
72205-195-01Isosulfan blue5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
72205-195-01722050195011 in 1 CARTONHistorical