PROVAYBLUE (Page 5 of 5)

Principal Display Panel — 50 mg/10 mL (5 mg/mL) Ampule Label

NDC 0517-0374-01

ProvayBlue ® (methylene blue) Injection USP

50 mg/10 mL (5 mg/mL)

Intravenous use only

Use 5% Dextrose in Water When Diluting

Single dose ampule — RX only

Discard unused portion

Manufactured by CENEXI for:

PROVEPHARM SAS

Distributed by:

AMERICAN REGENT, INC

Shirley, NY 11967

Ampule Label 10 mL
(click image for full-size original)

Principal Display Panel — 50 mg/10 mL (5 mg/mL) Carton Label

NDC 0517-0374-05 5 ampules

ProvayBlue®

(methylene blue) Injection USP, 0.5%

50 mg/10 mL (5 mg/mL)

Intravenous use only

For slow intravenous injection.

Use 5% Dextrose in Water When Diluting

10 mL — Single dose ampule
Discard unused portion

Rx only

Patented : US 8,765,942; US 9,227,945

Distributed by:

AMERICAN REGENT

10 mL Carton
(click image for full-size original)

Principal Display Panel — 10 mg/2 mL (5 mg/mL) Carton Label

NDC 0517-0125-05 5 ampules

ProvayBlue ®

(methylene blue) Injection USP 10 mg/2 mL (5 mg/mL)

Intravenous use only
For slow intravenous injection.
Use 5% Dextrose
in Water When Diluting

2 mL — Single dose ampule
Discard unused portion

Rx only

Patented: US 8,765,942; US 9,227,945

Distributed by:
AMERICAN
REGENT Shirley, NY 11967

2 mL Carton
(click image for full-size original)

Principal Display Panel — 10 mg/2 mL (5 mg/mL) Ampule Label

NDC 0517-0125-01

ProvayBlue®
(methylene blue) Injection USP
10 mg/2 mL (5 mg/mL)

Intravenous use only

Use 5% Dextrose in Water When
Diluting

Single dose ampule — RX only
Discard unused portion

Manufactured by CENEXI for:
PROVEPHARM SAS

Distributed by: AMERICAN REGENT, INC.

Shirley, NY 11967

2 mL Ampule Label
(click image for full-size original)
PROVAYBLUE methylene blue injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-0374
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLENE BLUE (METHYLENE BLUE CATION) METHYLENE BLUE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0517-0374-05 5 AMPULE in 1 CARTON contains a AMPULE (0517-0374-01)
1 NDC:0517-0374-01 10 mL in 1 AMPULE This package is contained within the CARTON (0517-0374-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204630 04/08/2016
PROVAYBLUE methylene blue injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-0125
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLENE BLUE (METHYLENE BLUE CATION) METHYLENE BLUE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0517-0125-05 5 AMPULE in 1 CARTON contains a AMPULE (0517-0125-01)
1 NDC:0517-0125-01 2 mL in 1 AMPULE This package is contained within the CARTON (0517-0125-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204630 04/08/2020
Labeler — American Regent, Inc. (002033710)
Registrant — Provepharm SAS (296789410)
Establishment
Name Address ID/FEI Operations
Cenexi 573309239 manufacture (0517-0374), manufacture (0517-0125)

Revised: 06/2021 American Regent, Inc.

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