NDC 70069-221

Isosulfan Blue

Isosulfan Blue

Isosulfan Blue is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Somerset Therapeutics, Llc. The primary component is Isosulfan Blue.

Product ID70069-221_70bc6d04-06a8-40ab-a5fd-2d955a4b4f1d
NDC70069-221
Product TypeHuman Prescription Drug
Proprietary NameIsosulfan Blue
Generic NameIsosulfan Blue
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2019-07-23
Marketing CategoryANDA / ANDA
Application NumberANDA210558
Labeler NameSomerset Therapeutics, LLC
Substance NameISOSULFAN BLUE
Active Ingredient Strength10 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70069-221-06

6 VIAL in 1 CARTON (70069-221-06) > 5 mL in 1 VIAL (70069-221-01)
Marketing Start Date2019-07-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70069-221-06 [70069022106]

Isosulfan Blue INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210558
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-23

NDC 70069-221-01 [70069022101]

Isosulfan Blue INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA210558
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-23

Drug Details

Active Ingredients

IngredientStrength
ISOSULFAN BLUE10 mg/mL

OpenFDA Data

SPL SET ID:a4c7400a-ff36-4a76-aa84-7f91e303f937
Manufacturer
UNII

NDC Crossover Matching brand name "Isosulfan Blue" or generic name "Isosulfan Blue"

NDCBrand NameGeneric Name
51808-206Isosulfan BlueIsosulfan Blue
55150-240Isosulfan BlueIsosulfan Blue
67457-220Isosulfan BlueIsosulfan Blue
67457-586Isosulfan BlueIsosulfan Blue
70069-221Isosulfan BlueIsosulfan Blue
71288-805Isosulfan BlueIsosulfan Blue
63261-250LYMPHAZURINisosulfan blue

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