METHYLENE BLUE

Product NDC
82432-104
11-digit product format
824320104
Labeler code
82432
Product ID
82432-104_496e0d21-41a6-070e-e063-6394a90a567f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLENE BLUE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Chengdu Shuode Pharmaceutical Co., Ltd
Application
ANDA219550
Marketing category
ANDA
Marketing start
2025-12-23
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

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
82432-104-01METHYLENE BLUE10 mL in 1 VIAL, SINGLE-DOSEINJECTION105
82432-104-02METHYLENE BLUE5 in 1 CARTONINJECTION55

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1788984methylene blue 50 MG in 10 ML InjectionPSNfe47491d-810e-466a-aab2-aa92756492ba5
178898410 ML methylene blue 5 MG/ML InjectionSCDfe47491d-810e-466a-aab2-aa92756492ba5
1788984methylene blue 50 MG per 10 ML InjectionSYfe47491d-810e-466a-aab2-aa92756492ba5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82432-104-018243201040110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
82432-104-02824320104025 VIAL, SINGLE-DOSE in 1 CARTON (82432-104-02) / 10 mL in 1 VIAL, SINGLE-DOSE (82432-104-01) 2025-12-23NoNoCurrent