Methylene Blue Injection
FDA Label NDC 70771-1963

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Methylene Blue (NDC 70771-1963). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

50 mg Per 10 mL Vial (C12095f8 Fb7f 4654 Bcaf E2068297c20d 01)

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

50 mg Per 10 mL Carton (C12095f8 Fb7f 4654 Bcaf E2068297c20d 02)

NDC 70771-1767-1

Methylene Blue Injection, USP

10 mg/2 mL (5 mg/mL)

Intravenous use only

Single-Dose vial

Rx only

10 mg Per 2 mL Carton (C12095f8 Fb7f 4654 Bcaf E2068297c20d 03)

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