Methylene Blue Injection, Usp

Methylene Blue Injection, Usp
SPL v2
SPL
SPL Set ID df3568d6-d509-4c93-9a92-0e3d1d8514dc
Route
INTRAVENOUS
Published
Effective Date 2024-04-24
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Methylene Blue Cation (5 mg)
Inactive Ingredients
Trisodium Citrate Dihydrate Anhydrous Citric Acid Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2023-12-05
Description

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 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 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

Medication Information

Description

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 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 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

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

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

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

Structured Label Content

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

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:40:51.906857 · Updated: 2026-03-14T22:04:26.530663