Methylene Blue

Product NDC
14789-119
11-digit product format
147890119
Labeler code
14789
Product ID
14789-119_2a32783c-572a-26cb-e063-6394a90af066
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylene Blue
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Nexus Pharmaceuticals, LLC
Application
ANDA217561
Marketing category
ANDA
Marketing start
2025-02-01
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLENE BLUE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT42P99266K
Rxcui1788984

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14789-119-05Methylene Blue5 in 1 CARTONINJECTION, SOLUTION58
14789-119-07Methylene Blue10 mL in 1 VIAL, GLASSINJECTION, SOLUTION108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14789-119METHYLENE BLUE INJECTION, SOLUTION [NEXUS PHARMACEUTICALS, LLC]8Current NDC, 2 package rows20250201_3484312e-ff43-4425-98e8-cd2ecf9f2a6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1788984methylene blue 50 MG in 10 ML InjectionPSN3484312e-ff43-4425-98e8-cd2ecf9f2a6d8
178898410 ML methylene blue 5 MG/ML InjectionSCD3484312e-ff43-4425-98e8-cd2ecf9f2a6d8
1788984methylene blue 50 MG per 10 ML InjectionSY3484312e-ff43-4425-98e8-cd2ecf9f2a6d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14789-119-05147890119055 VIAL, GLASS in 1 CARTON (14789-119-05) / 10 mL in 1 VIAL, GLASS (14789-119-07) 2025-02-01NoNoCurrent
14789-119-071478901190710 mL in 1 VIAL, GLASS10 mlHistorical