Home NDC 67457-220 Isosulfan Blue
Product NDC 67457-220
11-digit product format 674570220
Labeler code 67457
Product ID 67457-220_9c3ccc87-6252-4bd1-afda-4158ce4d66aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isosulfan Blue
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Mylan Institutional LLC
Application ANDA090874
Marketing category ANDA
Marketing start 2013-03-14
Substance ISOSULFAN BLUE
Active strength 10 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090874-001 ISOSULFAN BLUE ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 A090874-002 ISOSULFAN BLUE ISOSULFAN BLUE 10MG/ML (10MG/ML) SOLUTION / SUBCUTANEOUS RS 2026-01-28 A090874-003 ISOSULFAN BLUE ISOSULFAN BLUE 30MG/3ML (10MG/ML) SOLUTION / SUBCUTANEOUS RS 2026-01-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090874-001 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 · 45 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 2026-02-19 14:30 UTC 2026-02 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090874-002 ISOSULFAN BLUE 10MG/ML (10MG/ML) SOLUTION / SUBCUTANEOUS RS 2026-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090874-003 ISOSULFAN BLUE 30MG/3ML (10MG/ML) SOLUTION / SUBCUTANEOUS RS 2026-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Isosulfan Blue
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISOSULFAN BLUE 10 mg/mL
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 67457-220-05 Isosulfan Blue 6 in 1 CARTON INJECTION, SOLUTION 6 9 67457-220-05 Isosulfan Blue 5 mL in 1 VIAL, GLASS INJECTION, SOLUTION 5 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ISOSULFAN BLUE ACTIVE INGREDIENT 39N9K8S2A4 ISOSULFAN BLUE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 5 ISOSULFAN BLUE INNER SALT ACTIVE MOIETY NS6Q291771 ISOSULFAN BLUE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 5 POTASSIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 4J9FJ0HL51 ISOSULFAN BLUE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 5 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INACTIVE INGREDIENT 593YOG76RN ISOSULFAN BLUE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 5 WATER INACTIVE INGREDIENT 059QF0KO0R ISOSULFAN BLUE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-220 ISOSULFAN BLUE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 8 Current NDC, Legacy NDC, 2 package rows 20210203_1878964e-5220-48c8-a872-dcadbc451aff.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 Marketing start Marketing end Sample Exclude flag Status 67457-220-05 67457022005 6 VIAL, GLASS in 1 CARTON (67457-220-05) / 5 mL in 1 VIAL, GLASS 2013-03-14 0000-00-00 No No Current