NDC Code(s) : 0517-0301-10, 0517-0310-10, 0517-0372-71, 0517-0373-70
Packager : American Regent, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Methylene Blue Methylene Blue INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-0301
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLENE BLUE(UNII: T42P99266K)
(METHYLENE BLUE - UNII:T42P99266K) 		METHYLENE BLUE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-0301-1010 in 1 TRAY
11 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/30/1990
Methylene Blue Methylene Blue INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-0310
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLENE BLUE(UNII: T42P99266K)
(METHYLENE BLUE - UNII:T42P99266K) 		METHYLENE BLUE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-0310-1010 in 1 TRAY
110 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/30/1990
Methylene Blue Methylene Blue INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-0372
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLENE BLUE(UNII: T42P99266K)
(METHYLENE BLUE - UNII:T42P99266K) 		METHYLENE BLUE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-0372-7125 in 1 BOX
11 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/30/1990
Methylene Blue Methylene Blue INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-0373
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLENE BLUE(UNII: T42P99266K)
(METHYLENE BLUE - UNII:T42P99266K) 		METHYLENE BLUE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0517-0373-7025 in 1 BOX
110 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/30/1990

PRINCIPAL DISPLAY PANEL

PRINCIPLE DISPLAY PANEL –  1 mL Container

NDC 0517-0301-10

METHYLENE BLUE INJECTION, USP

1% (10 mg/mL)

1 mL SINGLE DOSE VIAL

FOR SLOW IV ADMINISTRATION

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY11967

e8ae0b66-figure-01

PRINCIPLE DISPLAY PANEL –  10 mL Container

NDC 0517-0310-10

METHYLENE BLUE INJECTION, USP

1% (10 mg/mL)

10 mL SINGLE DOSE VIAL

FOR SLOW INTRAVENOUS ADMINISTRATION

Rx Only

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

e8ae0b66-figure-01

PRINCIPLE DISPLAY PANEL –  1 mL Container

NDC 0517-0372-71

METHYLENE BLUE INJECTION, USP

1% (10 mg/mL)

1 mL AMPULE

FOR SLOW INTRAVENOUS ADMINISTRATION

Rx Only

Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature).

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Rev. 11/05

e8ae0b66-figure-01

PRINCIPLE DISPLAY PANEL –  10 mL Container

NDC 0517-0373-70

METHYLENE BLUE INJECTION, USP

1% (10 mg/mL)

10 mL AMPULE

FOR SLOW INTRAVENOUS ADMINISTRATION

Rx Only

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

e8ae0b66-figure-01