Home NDC 55150-240 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206831-001 ISOSULFAN BLUE ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2016-02-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206831-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A206831-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2016-02-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206831-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2016-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206831-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2016-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206831-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2016-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206831-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2016-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206831-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2016-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206831-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2016-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206831-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2016-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206831-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2016-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206831-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2016-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206831-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2016-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206831-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2016-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206831-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2016-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206831-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2016-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2016-02-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2016-02-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2016-02-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2016-02-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2016-02-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2016-02-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2016-02-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2016-02-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2016-02-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2016-02-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2016-02-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2016-02-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2016-02-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2016-02-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2016-02-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2016-02-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2016-02-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2016-02-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2016-02-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2016-02-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2016-02-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2016-02-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2016-02-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2016-02-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2016-02-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206831-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2016-02-02 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Isosulfan Blue
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOSULFAN BLUE 50 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 39N9K8S2A4 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55150-240-05 Isosulfan Blue 6 in 1 CARTON INJECTION, SOLUTION 6 5 55150-240-05 Isosulfan Blue 5 mL in 1 VIAL INJECTION, SOLUTION 5 5 55150-240-06 Isosulfan Blue 6 in 1 CARTON INJECTION, SOLUTION 6 3 55150-240-06 Isosulfan Blue 5 mL in 1 VIAL INJECTION, SOLUTION 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-240 ISOSULFAN BLUE INJECTION, SOLUTION [EUGIA US LLC] 4 Current NDC, Legacy NDC, 2 package rows 20240229_42f2d62a-c7f2-4706-87bc-64f3e72d63a9.zip 55150-240 ISOSULFAN BLUE INJECTION, SOLUTION [EUGIA US LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241218_61b48ff8-7ace-4ab7-9f58-f250e2830d16.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55150-240-05 55150024005 6 VIAL in 1 CARTON (55150-240-05) / 5 mL in 1 VIAL 6 vial 2016-02-02 0000-00-00 No No Current 55150-240-06 55150024006 6 VIAL in 1 CARTON (55150-240-06) / 5 mL in 1 VIAL 6 vial 2016-02-02 0000-00-00 No No Current