Last Updated: September 28, 2026

Details for New Drug Application (NDA): 219550

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NDA 219550 describes METHYLENE BLUE, which is a drug marketed by Chengdu Shuode, Hikma, Meitheal, Nexus, Steriscience, Xiromed, and Zydus Lifesciences, and is included in seven NDAs. It is available from eleven suppliers. Additional details are available on the METHYLENE BLUE profile page.

The generic ingredient in METHYLENE BLUE is methylene blue. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the methylene blue profile page.

Summary for 219550

Tradename:	METHYLENE BLUE
Applicant:	Chengdu Shuode
Ingredient:	methylene blue
Patents:	0

Pharmacology for NDA: 219550

Mechanism of Action	Oxidation-Reduction Activity

Medical Subject Heading (MeSH) Categories for 219550

Enzyme Inhibitors

Suppliers and Packaging for NDA: 219550

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	219550	ANDA	GLENMARK PHARMACEUTICALS INC., USA	68462-698	68462-698-15	5 VIAL, SINGLE-DOSE in 1 CARTON (68462-698-15) / 10 mL in 1 VIAL, SINGLE-DOSE (68462-698-10)
METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	219550	ANDA	Chengdu Shuode Pharmaceutical Co., Ltd	82432-104	82432-104-02	5 VIAL, SINGLE-DOSE in 1 CARTON (82432-104-02) / 10 mL in 1 VIAL, SINGLE-DOSE (82432-104-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	50MG/10ML (5MG/ML)
Approval Date:	Dec 23, 2025	TE:	AP	RLD:	No

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