FDA.reportPublic FDA data

Methylene blue

Product NDC
82449-002
11-digit product format
824490002
Labeler code
82449
Product ID
82449-002_4a8a9adf-f99b-6054-e063-6294a90ade62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylene Blue
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Steriscience Specialties Private Limited
Application
ANDA216955
Marketing category
ANDA
Marketing start
2025-02-28
Substance
METHYLENE BLUE
Active strength
50 mg/10mL
Pharmacologic classes
Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methylene blue
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLENE BLUE50 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT42P99266K
Rxcui1788984, 2731634

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
82449-002-01Methylene blue10 mL in 1 AMPULEINJECTION, SOLUTION103
82449-002-06Methylene blue5 in 1 CARTONINJECTION, SOLUTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82449-002METHYLENE BLUE INJECTION, SOLUTION [STERISCIENCE SPECIALTIES PRIVATE LIMITED]1Current NDC, 2 package rows20250228_eb87d31c-3a8e-4089-9693-20bc17279650.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2731634methylene blue 50 MG in 10 ML (0.5 % ) Prefilled SyringePSNeb87d31c-3a8e-4089-9693-20bc172796503
1788984methylene blue 50 MG in 10 ML InjectionPSNeb87d31c-3a8e-4089-9693-20bc172796503
178898410 ML methylene blue 5 MG/ML InjectionSCDeb87d31c-3a8e-4089-9693-20bc172796503
273163410 ML methylene blue 5 MG/ML Prefilled SyringeSCDeb87d31c-3a8e-4089-9693-20bc172796503
1788984methylene blue 50 MG per 10 ML InjectionSYeb87d31c-3a8e-4089-9693-20bc172796503
2731634methylene blue 50 MG per 10 ML Prefilled SyringeSYeb87d31c-3a8e-4089-9693-20bc172796503

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82449-002-018244900020110 mL in 1 AMPULE10 mlHistorical
82449-002-06824490002065 AMPULE in 1 CARTON (82449-002-06) / 10 mL in 1 AMPULE (82449-002-01) 5 ampule2025-02-28NoNoHistorical