Home NDC 82432-104 METHYLENE BLUE
Product NDC 82432-104
11-digit product format 824320104
Labeler code 82432
Product ID 82432-104_496e0d21-41a6-070e-e063-6394a90a567f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METHYLENE BLUE
Dosage form INJECTION
Route INTRAVENOUS
Labeler Chengdu Shuode Pharmaceutical Co., Ltd
Application ANDA219550
Marketing category ANDA
Marketing start 2025-12-23
Substance METHYLENE BLUE
Active strength 50 mg/10mL
Pharmacologic classes Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219550-001 METHYLENE BLUE METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2025-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219550-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A219550-001 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2025-12-23 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219550-001 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2025-12-23 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A219550-001 AP 1 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219550-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base METHYLENE BLUE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLENE BLUE 50 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T42P99266K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1788984 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82432-104-01 METHYLENE BLUE 10 mL in 1 VIAL, SINGLE-DOSE INJECTION 10 5 82432-104-02 METHYLENE BLUE 5 in 1 CARTON INJECTION 5 5
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82432-104-01 82432010401 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 82432-104-02 82432010402 5 VIAL, SINGLE-DOSE in 1 CARTON (82432-104-02) / 10 mL in 1 VIAL, SINGLE-DOSE (82432-104-01) 2025-12-23 No No Current