FDA.reportPublic FDA data

Methylene Blue

Product NDC
71288-811
11-digit product format
712880811
Labeler code
71288
Product ID
71288-811_65ff33db-d8c2-4591-8988-78e08b2298b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylene Blue
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA217380
Marketing category
ANDA
Marketing start
2025-01-23
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methylene Blue
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLENE BLUE5 mg/mL

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
71288-811-10Methylene Blue10 mL in 1 VIAL, SINGLE-DOSEINJECTION108
71288-811-11Methylene Blue5 in 1 CARTONINJECTION58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-811-10ML - Milliliter71288-811b53c63e7-5947-4714-9bc0-46f0d7f999e112025-02-10
71288-811-11ML - Milliliter71288-811499feb7b-a9bb-42e3-8f4c-a838a3d29cad12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-811METHYLENE BLUE INJECTION [MEITHEAL PHARMACEUTICALS INC.]8Current NDC, 2 package rows20250205_2566ce72-9d19-42e5-80f9-8fc4612b1eff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1788984methylene blue 50 MG in 10 ML InjectionPSN2566ce72-9d19-42e5-80f9-8fc4612b1eff8
178898410 ML methylene blue 5 MG/ML InjectionSCD2566ce72-9d19-42e5-80f9-8fc4612b1eff8
1788984methylene blue 50 MG per 10 ML InjectionSY2566ce72-9d19-42e5-80f9-8fc4612b1eff8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71288-811-107128808111010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
71288-811-11712880811115 VIAL, SINGLE-DOSE in 1 CARTON (71288-811-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-811-10) 2025-01-23NoNoHistorical