FDA.reportPublic FDA data

Methylene blue

Product NDC
70771-1768
11-digit product format
707711768
Labeler code
70771
Product ID
70771-1768_31d0470b-20e5-4d5e-b273-81d5dd6b2180
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylene blue
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Zydus Lifesciences Limited
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
70771-1768-1Methylene blue10 mL in 1 VIALINJECTION103
70771-1768-5Methylene blue5 in 1 CARTONINJECTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1768METHYLENE BLUE INJECTION [ZYDUS LIFESCIENCES LIMITED]2Current NDC, 2 package rows20240426_df3568d6-d509-4c93-9a92-0e3d1d8514dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2199323methylene blue 10 MG in 2 mL InjectionPSNdf3568d6-d509-4c93-9a92-0e3d1d8514dc3
1737852methylene blue 100 MG in 10 ML (1 % ) InjectionPSNdf3568d6-d509-4c93-9a92-0e3d1d8514dc3
1788984methylene blue 50 MG in 10 ML InjectionPSNdf3568d6-d509-4c93-9a92-0e3d1d8514dc3
173785210 ML methylene blue 10 MG/ML InjectionSCDdf3568d6-d509-4c93-9a92-0e3d1d8514dc3
178898410 ML methylene blue 5 MG/ML InjectionSCDdf3568d6-d509-4c93-9a92-0e3d1d8514dc3
21993232 ML methylene blue 5 MG/ML InjectionSCDdf3568d6-d509-4c93-9a92-0e3d1d8514dc3
2199323methylene blue 10 MG per 2 ML InjectionSYdf3568d6-d509-4c93-9a92-0e3d1d8514dc3
1737852methylene blue 100 MG per 10 ML (1 % ) InjectionSYdf3568d6-d509-4c93-9a92-0e3d1d8514dc3
1788984methylene blue 50 MG per 10 ML InjectionSYdf3568d6-d509-4c93-9a92-0e3d1d8514dc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1768-17077117680110 mL in 1 VIAL10 mlHistorical
70771-1768-5707711768055 VIAL in 1 CARTON (70771-1768-5) / 10 mL in 1 VIAL (70771-1768-1) 5 vial2023-12-05NoNoHistorical