Home NDC 81284-315 BLUDIGO
Product NDC 81284-315
11-digit product format 812840315
Labeler code 81284
Product ID 81284-315_2d60b6a4-17d2-4864-b01c-9862283da8de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name indigotindisulfonate sodium
Dosage form INJECTION
Route INTRAVENOUS
Labeler Provepharm Inc.
Application NDA216264
Marketing category NDA
Marketing start 2022-09-06
Substance INDIGOTINDISULFONATE SODIUM
Active strength 8 mg/mL
Pharmacologic classes Diagnostic Dye [EPC], Dyes [MoA]
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 N216264-001 BLUDIGO INDIGOTINDISULFONATE SODIUM 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216264-001 11845867 2036-11-25 Drug substance 2024-01-11 N216264-001 10927258 2037-12-23 Drug substance 2022-08-01 N216264-001 11499050 2037-12-23 Drug substance 2022-11-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216264-001 NCE 2027-07-08
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 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216264-001 BLUDIGO 40MG/5ML (8MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-08 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 71 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N216264-001 11845867 2036-11-25 Drug substance 2024-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216264-001 10927258 2037-12-23 Drug substance 2022-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216264-001 11499050 2037-12-23 Drug substance 2022-11-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216264-001 11845867 2036-11-25 Drug substance 2024-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216264-001 10927258 2037-12-23 Drug substance 2022-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216264-001 11499050 2037-12-23 Drug substance 2022-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216264-001 11845867 2036-11-25 Drug substance 2024-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216264-001 10927258 2037-12-23 Drug substance 2022-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216264-001 11499050 2037-12-23 Drug substance 2022-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216264-001 11845867 2036-11-25 Drug substance 2024-01-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216264-001 10927258 2037-12-23 Drug substance 2022-08-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216264-001 11499050 2037-12-23 Drug substance 2022-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216264-001 11845867 2036-11-25 Drug substance 2024-01-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216264-001 10927258 2037-12-23 Drug substance 2022-08-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216264-001 11499050 2037-12-23 Drug substance 2022-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216264-001 11845867 2036-11-25 Drug substance 2024-01-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216264-001 10927258 2037-12-23 Drug substance 2022-08-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216264-001 11499050 2037-12-23 Drug substance 2022-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216264-001 11845867 2036-11-25 Drug substance 2024-01-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216264-001 10927258 2037-12-23 Drug substance 2022-08-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216264-001 11499050 2037-12-23 Drug substance 2022-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216264-001 11845867 2036-11-25 Drug substance 2024-01-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216264-001 10927258 2037-12-23 Drug substance 2022-08-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216264-001 11499050 2037-12-23 Drug substance 2022-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216264-001 11845867 2036-11-25 Drug substance 2024-01-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216264-001 10927258 2037-12-23 Drug substance 2022-08-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216264-001 11499050 2037-12-23 Drug substance 2022-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216264-001 11845867 2036-11-25 Drug substance 2024-01-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216264-001 10927258 2037-12-23 Drug substance 2022-08-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216264-001 11499050 2037-12-23 Drug substance 2022-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216264-001 11845867 2036-11-25 Drug substance 2024-01-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216264-001 10927258 2037-12-23 Drug substance 2022-08-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N216264-001 11499050 2037-12-23 Drug substance 2022-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216264-001 11845867 2036-11-25 Drug substance 2024-01-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216264-001 10927258 2037-12-23 Drug substance 2022-08-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216264-001 11499050 2037-12-23 Drug substance 2022-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216264-001 11845867 2036-11-25 Drug substance 2024-01-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216264-001 10927258 2037-12-23 Drug substance 2022-08-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216264-001 11499050 2037-12-23 Drug substance 2022-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216264-001 11845867 2036-11-25 Drug substance 2024-01-11 1e350fbaab3a…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base BLUDIGO
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength INDIGOTINDISULFONATE SODIUM 8 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D3741U8K7L 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 81284-315-00 BLUDIGO 5 mL in 1 AMPULE INJECTION 5 6 81284-315-05 BLUDIGO 5 in 1 CARTON INJECTION 5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81284-315 BLUDIGO (INDIGOTINDISULFONATE SODIUM) INJECTION [PROVEPHARM INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240522_73f246c4-b127-452e-856f-134b56cb8870.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 81284-315-00 81284031500 5 mL in 1 AMPULE 5 ml Historical 81284-315-05 81284031505 5 AMPULE in 1 CARTON (81284-315-05) / 5 mL in 1 AMPULE (81284-315-00) 5 ampule 2022-09-06 0000-00-00 No No Current