Home NDC 54288-159-05 Methylene Blue
Product NDC 54288-159
Requested package NDC 54288-159-05
11-digit product format 542880159
Labeler code 54288
Product ID 54288-159_e36054e3-076c-46d7-82f1-33b3d9481376
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylene Blue
Dosage form INJECTION
Route INTRAVENOUS
Labeler BPI LABS LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2023-05-15
Substance METHYLENE BLUE
Active strength 10 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 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 · 3 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 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 54288-159 54288-159-05 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 54288-159 54288-159-05 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 54288-159 54288-159-05 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Methylene Blue
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLENE 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 T42P99266K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2637038 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54288-159-01 Methylene Blue 2 mL in 1 SYRINGE INJECTION 2 5 54288-159-05 Methylene Blue 5 in 1 PACKAGE INJECTION 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54288-159 METHYLENE BLUE INJECTION [BPI LABS LLC] 3 Current NDC, 2 package rows 20250213_fbdd583d-45ba-4d42-8c80-9a13b71980b6.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 Sample Exclude flag Status 54288-159-05 54288015905 5 SYRINGE in 1 PACKAGE (54288-159-05) / 2 mL in 1 SYRINGE (54288-159-01) 5 syringe 2023-05-15 No No Current