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 (31d0470b 20e5 4d5e B273 81d5dd6b2180 01)

NDC 70771-1768-5

Methylene Blue Injection, USP

50 mg/10 mL (5 mg/mL)

Intravenous use only

5 X 10 mL Single-Dose Vial

Rx only

50 mg Per 10 mL Carton (31d0470b 20e5 4d5e B273 81d5dd6b2180 02)

NDC 70771-1767-1

Methylene Blue Injection, USP

10 mg/2 mL (5 mg/mL)

Intravenous use only

Single-Dose vial

Rx only

Image (31d0470b 20e5 4d5e B273 81d5dd6b2180 03)

NDC 70771-1767-5

Methylene Blue Injection, USP

10 mg/2 mL (5 mg/mL)

Intravenous use only

5 X 2 mL Single-Dose Vial

Rx only

10 mg Per 2 mL Carton (31d0470b 20e5 4d5e B273 81d5dd6b2180 04)

NDC 70771-1963-1

Methylene Blue Injection, USP

100 mg/10 mL (10 mg/mL)

Intravenous use only

Single-Dose Vial

Rx only

Zydus

Image (31d0470b 20e5 4d5e B273 81d5dd6b2180 05)

70771-1963-5

Methylene Blue Injection, USP

100 mg/10 mL (10 mg/mL) (1%)

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

Zydus

Image (31d0470b 20e5 4d5e B273 81d5dd6b2180 06)

Methylene Blue Injection
FDA Label NDC 70771-1963

Structured Product Label

Label Section Quick Index

Package Label.Principal Display Panel