Home NDC 73043-093 Isosulfan Blue
Product NDC 73043-093
11-digit product format 730430093
Labeler code 73043
Product ID 73043-093_2b782bc5-e7fb-48de-99fe-d17ef2cef094
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isosulfan Blue
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Devatis, Inc.
Application ANDA210714
Marketing category ANDA
Marketing start 2026-06-30
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 43 .
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 A210714-001 ISOSULFAN BLUE ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2019-01-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210714-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2019-01-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2019-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2019-01-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 73043-093-06 73043009306 6 VIAL, GLASS in 1 CARTON (73043-093-06) / 5 mL in 1 VIAL, GLASS (73043-093-01) 2026-06-30 No No Current