FDA.reportPublic FDA data

Methylene Blue

Product NDC
54288-159
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

Additional Listing Data#

Finished product
Yes
Brand name base
Methylene Blue
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLENE BLUE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT42P99266K
Rxcui2637038

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c39b72c3-7732-4ed2-a995-e6aa3a665a54Product name320250819

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54288-159-052025-02-11C16284748780-12cef2736-7566-d83d-e063-dadaa90ab31fMethylene Blue Injection, USP 1%
54288-159-052025-01-30C16284748780-12cef2736-7566-d83d-e063-dadaa90ab31fMethylene Blue Injection, USP 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54288-159-01Methylene Blue2 mL in 1 SYRINGEINJECTION25
54288-159-05Methylene Blue5 in 1 PACKAGEINJECTION55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54288-159-01ML - Milliliter54288-159482829ce-5c1c-49f7-9ad9-8fb1377a90e812024-01-04
54288-159-05ML - Milliliter54288-159c182b316-2272-4724-a1a9-5942b6fe783912024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-159METHYLENE BLUE INJECTION [BPI LABS LLC]3Current NDC, 2 package rows20250213_fbdd583d-45ba-4d42-8c80-9a13b71980b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637038methylene blue 20 MG in 2 ML (1 % ) Prefilled SyringePSNfbdd583d-45ba-4d42-8c80-9a13b71980b65
26370382 ML methylene blue 10 MG/ML Prefilled SyringeSCDfbdd583d-45ba-4d42-8c80-9a13b71980b65
2637038methylene blue 20 MG per 2 ML Prefilled SyringeSYfbdd583d-45ba-4d42-8c80-9a13b71980b65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54288-159-01542880159012 mL in 1 SYRINGE2 mlHistorical
54288-159-05542880159055 SYRINGE in 1 PACKAGE (54288-159-05) / 2 mL in 1 SYRINGE (54288-159-01) 5 syringe2023-05-15NoNoHistorical