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FDA Drug information

Methylene blue

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20231205

Version

1

Spl Product Data Elements

Methylene blue Methylene blue METHYLENE BLUE METHYLENE BLUE CATION TRISODIUM CITRATE DIHYDRATE ANHYDROUS CITRIC ACID WATER Methylene blue Methylene blue METHYLENE BLUE METHYLENE BLUE CATION TRISODIUM CITRATE DIHYDRATE ANHYDROUS CITRIC ACID WATER

Application Number

ANDA215636

Brand Name

Methylene blue

Generic Name

Methylene blue

Product Ndc

70771-1767

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

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 50 mg per 10 mL vial 50 mg per 10 mL carton 10 mg per 2 mL carton

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