Home NDC 82454-0125 PROVAYBLUE
Product NDC 82454-0125
11-digit product format 824540125
Labeler code 82454
Product ID 82454-0125_d3379939-6ce8-2e97-e053-2995a90a8755
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methylene blue
Dosage form INJECTION
Route INTRAVENOUS
Labeler CENEXI HSC
Application NDA204630
Marketing category NDA
Marketing start 2020-04-08
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 3 · 82 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 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204630-001 PROVAYBLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2016-04-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204630-002 PROVAYBLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-07-18 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 76 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PROVAYBLUE METHYLENE BLUE American Regent, Inc. 4f6848e5-35ed-4046-b13c-3032b5ba3232 2025-05-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 204630 application number: NDA204630
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82454-0125-5 82454012505 5 AMPULE in 1 CARTON (82454-0125-5) > 2 mL in 1 AMPULE (82454-0125-1) 5 ampule 2020-04-08 0000-00-00 No No Current