METHYLENE BLUE

Product NDC
70700-328
11-digit product format
707000328
Labeler code
70700
Product ID
70700-328_3eddefa4-0024-493a-e063-6294a90a1b49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLENE BLUE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
XIROMED, LLC
Application
ANDA219363
Marketing category
ANDA
Marketing start
2025-09-28
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
2026-12-31
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

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
70700-328-22METHYLENE BLUE10 mL in 1 VIAL, SINGLE-DOSEINJECTION101
70700-328-24METHYLENE BLUE5 in 1 CARTONINJECTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-328-22ML - Milliliter70700-328922f84ea-0ea7-4131-8ca6-e1af05a542b712025-11-13
70700-328-24ML - Milliliter70700-328fde7c165-a98e-4649-89ac-551ded3f900912025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1788984methylene blue 50 MG in 10 ML InjectionPSN691a6872-bc2f-d492-11c6-c3eec25aa3d31
178898410 ML methylene blue 5 MG/ML InjectionSCD691a6872-bc2f-d492-11c6-c3eec25aa3d31
1788984methylene blue 50 MG per 10 ML InjectionSY691a6872-bc2f-d492-11c6-c3eec25aa3d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70700-328-227070003282210 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
70700-328-24707000328245 VIAL, SINGLE-DOSE in 1 CARTON (70700-328-24) / 10 mL in 1 VIAL, SINGLE-DOSE (70700-328-22) 2025-09-28NoNoCurrent