Home NDC 70069-221 Isosulfan Blue
Product NDC 70069-221
11-digit product format 700690221
Labeler code 70069
Product ID 70069-221_ed436868-8729-4a79-b5b5-15c1b12bde81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isosulfan Blue
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Somerset Therapeutics, LLC
Application ANDA210558
Marketing category ANDA
Marketing start 2019-07-23
Substance ISOSULFAN BLUE
Active strength 10 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 70069-221 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A210558-001 ISOSULFAN BLUE ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2019-07-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210558-001 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.
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 A210558-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210558-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210558-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210558-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210558-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210558-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210558-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210558-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210558-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210558-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210558-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210558-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-07-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210558-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-07-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2019-07-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2019-07-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2019-07-12 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210558-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-07-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210558-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2019-07-12 a50c72e98297…
Observed Orange Book normalized TE history# 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 70069-221-01 Isosulfan Blue 5 mL in 1 VIAL INJECTION, SOLUTION 5 4 70069-221-06 Isosulfan Blue 6 in 1 CARTON INJECTION, SOLUTION 6 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-221 ISOSULFAN BLUE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20250112_a4c7400a-ff36-4a76-aa84-7f91e303f937.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 · 1 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 70069-221-01 70069022101 5 mL in 1 VIAL 5 ml Historical 70069-221-06 70069022106 6 VIAL in 1 CARTON (70069-221-06) / 5 mL in 1 VIAL (70069-221-01) 6 vial 2019-07-23 0000-00-00 No No Current