Home NDC 71288-805 Isosulfan Blue
Product NDC 71288-805
11-digit product format 712880805
Labeler code 71288
Product ID 71288-805_1c9d3281-9ee0-4e8c-9d36-7736ada64138
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Isosulfan Blue
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA213130
Marketing category ANDA
Marketing start 2021-11-03
Substance ISOSULFAN BLUE
Active strength 10 mg/mL
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 A213130-001 ISOSULFAN BLUE ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-11-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213130-001 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 2026-08-18 06:07:40 2026-07 A213130-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-11-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213130-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-11-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213130-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-11-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213130-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-11-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213130-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-11-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213130-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-11-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213130-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-11-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213130-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-11-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213130-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-11-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213130-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-11-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213130-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-11-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213130-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-11-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213130-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-11-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213130-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-11-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213130-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2021-11-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213130-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2021-11-03 a50c72e98297…
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 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 71288-805-05 Isosulfan Blue 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 4 71288-805-06 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 71288-805 ISOSULFAN BLUE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 4 Current NDC, Legacy NDC, 2 package rows 20211106_d36ae5af-6351-497a-9151-82bcb2c62fa0.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 71288-805-05 71288080505 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical 71288-805-06 71288080506 6 VIAL, SINGLE-DOSE in 1 CARTON (71288-805-06) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-805-05) 2021-11-03 0000-00-00 No No Current