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Active ingredient

Methylene Blue

25 finished FDA listings contain Methylene Blue as their only active ingredient; 11 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
METHYLENE BLUE, METHYLENE BLUE ANHYDROUS
Dosage forms
Injection, Injection, Solution, Solution
Routes
Extracorporeal, Intravenous
Manufacturers / labelers
15
Strengths listed
1 g/100ml · 10 mg/ml · 5 mg/ml · 50 mg/10ml
Brand names in FDA listings
Arthcal 1% Methylene Blue, Ozipco 1% Methylene Blue, Provayblue

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6878

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 204630PROVEPHARM SAS2016-04-084
ANDA 215636ZYDUS LIFESCIENCES2023-12-056
ANDA 217561NEXUS2024-11-212
ANDA 216955STERISCIENCE2024-11-224
ANDA 216959HIKMA2024-12-171
ANDA 217380MEITHEAL2025-01-231
ANDA 219363XIROMED2025-07-301
ANDA 219550CHENGDU SHUODE2025-12-232

Official labeling on DailyMed

Showing the 12 most recent of 16 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.