Methylene blue

Product NDC
70121-2715
11-digit product format
701212715
Labeler code
70121
Product ID
70121-2715_3d0c528f-71c3-4517-93f8-901307496e01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylene blue
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA216955
Marketing category
ANDA
Marketing start
2025-03-03
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
Rxcui1788984, 2731634

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
70121-2715-2Methylene blue10 in 1 BOXINJECTION, SOLUTION102
70121-2715-3Methylene blue10 mL in 1 AMPULEINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-2715-2ML - Milliliter70121-27155bd865c2-cf51-4bd4-bc58-270732b10c3812025-05-14
70121-2715-3ML - Milliliter70121-2715b98e7244-f87e-4a44-99a6-1b090a68ccbe12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-2715METHYLENE BLUE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC]1Current NDC, 2 package rows20250328_67da2a69-8166-46c7-921c-d6ec47bfeac8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2731634methylene blue 50 MG in 10 ML (0.5 % ) Prefilled SyringePSN67da2a69-8166-46c7-921c-d6ec47bfeac82
1788984methylene blue 50 MG in 10 ML InjectionPSN67da2a69-8166-46c7-921c-d6ec47bfeac82
178898410 ML methylene blue 5 MG/ML InjectionSCD67da2a69-8166-46c7-921c-d6ec47bfeac82
273163410 ML methylene blue 5 MG/ML Prefilled SyringeSCD67da2a69-8166-46c7-921c-d6ec47bfeac82
1788984methylene blue 50 MG per 10 ML InjectionSY67da2a69-8166-46c7-921c-d6ec47bfeac82
2731634methylene blue 50 MG per 10 ML Prefilled SyringeSY67da2a69-8166-46c7-921c-d6ec47bfeac82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70121-2715-27012127150210 AMPULE in 1 BOX (70121-2715-2) / 10 mL in 1 AMPULE (70121-2715-3) 10 ampule2025-03-03NoNoCurrent
70121-2715-37012127150310 mL in 1 AMPULE10 mlHistorical