Label: METHYLENE BLUE injection
- NDC Code(s): 70771-1767-1, 70771-1767-5, 70771-1768-1, 70771-1768-5
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 24, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Methylene Blue Injection, USP
50 mg/10 mL (5 mg/mL)
Intravenous use only
Single-Dose vial
Rx only
Methylene Blue Injection, USP
50 mg/10 mL (5 mg/mL)
Intravenous use only
5 X 10 mL Single-Dose Vial
Rx only
Methylene Blue Injection, USP
10 mg/2 mL (5 mg/mL)
Intravenous use only
Single-Dose vial
Rx only
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 injectionProduct 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 injectionProduct 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)