FDA Label for Methylene Blue

View Indications, Usage & Precautions

Methylene Blue Product Label

The following document was submitted to the FDA by the labeler of this product Zydus Lifesciences Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Package Label.Principal Display Panel



NDC 70771-1768-1

Methylene Blue Injection, USP

50 mg/10 mL (5 mg/mL)

Intravenous use only

Single-Dose vial

Rx only

NDC 70771-1768-5

Methylene Blue Injection, USP

50 mg/10 mL (5 mg/mL)

Intravenous use only

For slow intravenous injection

Use 5% Dextrose Injection When Diluting

Discard unused portion

5 X 10 mL Single-Dose vial

Rx only

NDC 70771-1767-1

Methylene Blue Injection, USP

10 mg/2 mL (5 mg/mL)

Intravenous use only

Single-Dose vial

Rx only


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