MedPath

Methylene Blue

Methylene Blue Injection 1%

Approved
Approval ID

fbdd583d-45ba-4d42-8c80-9a13b71980b6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 5, 2023

Manufacturers
FDA

BPI LABS LLC

DUNS: 078627620

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Methylene Blue

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54288-159
Product Classification
G
Generic Name
Methylene Blue
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 5, 2023
FDA Product Classification

INGREDIENTS (4)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
METHYLENE BLUEActive
Quantity: 10 mg in 1 mL
Code: T42P99266K
Classification: ACTIB

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