FDA.reportPublic FDA data

Methylene blue

Product NDC
70710-1837
11-digit product format
707101837
Labeler code
70710
Product ID
70710-1837_9a71c3d4-778d-4566-a060-8ec69cf93871
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylene blue
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA215636
Marketing category
ANDA
Marketing start
2023-12-05
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
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 BLUE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT42P99266K
Rxcui1737852, 1788984, 2199323

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
70710-1837-1Methylene blue2 mL in 1 VIALINJECTION210
70710-1837-5Methylene blue5 in 1 CARTONINJECTION510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1837METHYLENE BLUE INJECTION [ZYDUS PHARMACEUTICALS USA INC.]9Current NDC, 2 package rows20250309_8c56fbad-a449-4ed4-a55f-1694e4e8e26a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2199323methylene blue 10 MG in 2 mL InjectionPSN8c56fbad-a449-4ed4-a55f-1694e4e8e26a10
1737852methylene blue 100 MG in 10 ML (1 % ) InjectionPSN8c56fbad-a449-4ed4-a55f-1694e4e8e26a10
1788984methylene blue 50 MG in 10 ML InjectionPSN8c56fbad-a449-4ed4-a55f-1694e4e8e26a10
173785210 ML methylene blue 10 MG/ML InjectionSCD8c56fbad-a449-4ed4-a55f-1694e4e8e26a10
178898410 ML methylene blue 5 MG/ML InjectionSCD8c56fbad-a449-4ed4-a55f-1694e4e8e26a10
21993232 ML methylene blue 5 MG/ML InjectionSCD8c56fbad-a449-4ed4-a55f-1694e4e8e26a10
2199323methylene blue 10 MG per 2 ML InjectionSY8c56fbad-a449-4ed4-a55f-1694e4e8e26a10
1737852methylene blue 100 MG per 10 ML (1 % ) InjectionSY8c56fbad-a449-4ed4-a55f-1694e4e8e26a10
1788984methylene blue 50 MG per 10 ML InjectionSY8c56fbad-a449-4ed4-a55f-1694e4e8e26a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1837-1707101837012 mL in 1 VIAL2 mlHistorical
70710-1837-5707101837055 VIAL in 1 CARTON (70710-1837-5) / 2 mL in 1 VIAL (70710-1837-1) 5 vial2023-12-05NoNoCurrent