Home NDC 0517-0371 PROVAYBLUE
Product NDC 0517-0371
11-digit product format 005170371
Labeler code 0517
Product ID 0517-0371_420bd985-ac55-44b9-b8a0-a5098220575b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methylene blue
Dosage form INJECTION
Route INTRAVENOUS
Labeler American Regent, Inc.
Application NDA204630
Marketing category NDA
Marketing start 2020-04-08
Substance METHYLENE BLUE
Active strength 5 mg/mL
Pharmacologic classes Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204630-001 PROVAYBLUE METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 N204630-002 PROVAYBLUE METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N204630-001 M-303 2027-01-08 N204630-002 M-303 2027-01-08
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.
Product history page 1 of 2 · 78 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 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-04-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-04-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-04-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-04-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-04-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-04-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2019-07-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-04-08 87673890dc5c…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 72 observed states.
Additional Listing Data#
Finished product Yes
Brand name base PROVAYBLUE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLENE BLUE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T42P99266K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1788984 Internal RxNorm lookup 1788989 Internal RxNorm lookup 2199323 Internal RxNorm lookup 2199324 Internal RxNorm 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 0517-0371-01 PROVAYBLUE 2 mL in 1 VIAL, SINGLE-DOSE INJECTION 2 28 0517-0371-05 PROVAYBLUE 5 in 1 CARTON INJECTION 5 28
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0517-0371 PROVAYBLUE (METHYLENE BLUE) INJECTION [AMERICAN REGENT, INC.] 27 Current NDC, Legacy NDC, 2 package rows 20241222_4f6848e5-35ed-4046-b13c-3032b5ba3232.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0517-0371-01 00517037101 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical 0517-0371-05 00517037105 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-0371-05) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-0371-01) 2021-12-31 0000-00-00 No No Current