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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 219363

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NDA 219363 describes METHYLENE BLUE, which is a drug marketed by Hikma, Meitheal, Nexus, Steriscience, Xiromed, and Zydus Lifesciences, and is included in six NDAs. It is available from eight suppliers. Additional details are available on the METHYLENE BLUE profile page.

The generic ingredient in METHYLENE BLUE is methylene blue. There are twenty-five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the methylene blue profile page.

Summary for 219363

Tradename:	METHYLENE BLUE
Applicant:	Xiromed
Ingredient:	methylene blue
Patents:	0

Pharmacology for NDA: 219363

Mechanism of Action	Oxidation-Reduction Activity

Medical Subject Heading (MeSH) Categories for 219363

Enzyme Inhibitors

Suppliers and Packaging for NDA: 219363

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	219363	ANDA	XIROMED, LLC	70700-328	70700-328-24	5 VIAL, SINGLE-DOSE in 1 CARTON (70700-328-24) / 10 mL in 1 VIAL, SINGLE-DOSE (70700-328-22)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	50MG/10ML (5MG/ML)
Approval Date:	Jul 30, 2025	TE:	AP	RLD:	No

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