methylene blue

Generic: methylene blue

Labeler: nexus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylene blue
Generic Name methylene blue
Labeler nexus pharmaceuticals, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

methylene blue 5 mg/mL

Manufacturer
Nexus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 14789-119
Product ID 14789-119_2a32783c-572a-26cb-e063-6394a90af066
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217561
Listing Expiration 2026-12-31
Marketing Start 2025-02-01

Pharmacologic Class

Classes
oxidation-reduction activity [moa] oxidation-reduction agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14789119
Hyphenated Format 14789-119

Supplemental Identifiers

RxCUI
1788984
UNII
T42P99266K

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name methylene blue (source: ndc)
Generic Name methylene blue (source: ndc)
Application Number ANDA217561 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 5 VIAL, GLASS in 1 CARTON (14789-119-05) / 10 mL in 1 VIAL, GLASS (14789-119-07)
source: ndc

Packages (1)

14789-119-05 5 VIAL, GLASS in 1 CARTON (14789-119-05) / 10 mL in 1 VIAL, GLASS (14789-119-07)

Ingredients (1)

methylene blue (5 mg/mL)

Linked Drug Pages (1)

Methylene Blue ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2a32783c-572a-26cb-e063-6394a90af066", "openfda": {"unii": ["T42P99266K"], "rxcui": ["1788984"], "spl_set_id": ["3484312e-ff43-4425-98e8-cd2ecf9f2a6d"], "manufacturer_name": ["Nexus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, GLASS in 1 CARTON (14789-119-05)  / 10 mL in 1 VIAL, GLASS (14789-119-07)", "package_ndc": "14789-119-05", "marketing_start_date": "20250201"}], "brand_name": "Methylene Blue", "product_id": "14789-119_2a32783c-572a-26cb-e063-6394a90af066", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Oxidation-Reduction Activity [MoA]", "Oxidation-Reduction Agent [EPC]"], "product_ndc": "14789-119", "generic_name": "Methylene Blue", "labeler_name": "Nexus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylene Blue", "active_ingredients": [{"name": "METHYLENE BLUE", "strength": "5 mg/mL"}], "application_number": "ANDA217561", "marketing_category": "ANDA", "marketing_start_date": "20250201", "listing_expiration_date": "20261231"}