Methylene Blue

Product NDC
54288-147
11-digit product format
542880147
Labeler code
54288
Product ID
54288-147_b94f7574-e7a9-4c69-b915-6e88f226021d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylene Blue
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
BPI LABS LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-12-23
Substance
METHYLENE BLUE
Active strength
10 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 BLUE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT42P99266K
Rxcui1737852

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
54288-147-01Methylene Blue10 mL in 1 VIALINJECTION108
54288-147-01Methylene Blue1 in 1 CARTONINJECTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54288-147-01ML - Milliliter54288-1474c0f9189-2f77-486c-b350-000f2654554112022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-147METHYLENE BLUE INJECTION [BPI LABS LLC]6Current NDC, Legacy NDC, 2 package rows20250213_e2d9d96c-a711-47c5-855a-7eb7f163493e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737852methylene blue 100 MG in 10 ML (1 % ) InjectionPSNe2d9d96c-a711-47c5-855a-7eb7f163493e8
173785210 ML methylene blue 10 MG/ML InjectionSCDe2d9d96c-a711-47c5-855a-7eb7f163493e8
1737852methylene blue 100 MG per 10 ML (1 % ) InjectionSYe2d9d96c-a711-47c5-855a-7eb7f163493e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54288-147-01542880147011 VIAL in 1 CARTON (54288-147-01) / 10 mL in 1 VIAL1 vial2021-12-230000-00-00NoNoCurrent