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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 216955

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NDA 216955 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 216955

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

Pharmacology for NDA: 216955

Mechanism of Action	Oxidation-Reduction Activity

Medical Subject Heading (MeSH) Categories for 216955

Enzyme Inhibitors

Suppliers and Packaging for NDA: 216955

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	216955	ANDA	Amneal Pharmaceuticals LLC	70121-2715	70121-2715-2	10 AMPULE in 1 BOX (70121-2715-2) / 10 mL in 1 AMPULE (70121-2715-3)
METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	216955	ANDA	Steriscience Specialties Private Limited	82449-002	82449-002-06	5 AMPULE in 1 CARTON (82449-002-06) / 10 mL in 1 AMPULE (82449-002-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	50MG/10ML (5MG/ML)
Approval Date:	Nov 22, 2024	TE:	AP	RLD:	No

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