METHYLENE BLUE injection

Methylene blue by

Drug Labeling and Warnings

Methylene blue by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

METHYLENE BLUE 
methylene blue injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1767
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH)	METHYLENE BLUE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1767-5	5 in 1 CARTON	12/05/2023
1	NDC: 70771-1767-1	2 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215636	12/05/2023

METHYLENE BLUE 
methylene blue injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1768
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH)	METHYLENE BLUE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1768-5	5 in 1 CARTON	12/05/2023
1	NDC: 70771-1768-1	10 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215636	12/05/2023

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		873671928	MANUFACTURE(70771-1767, 70771-1768) , ANALYSIS(70771-1767, 70771-1768)