methylene blue

Generic: methylene blue

Labeler: steriscience specialties private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylene blue
Generic Name methylene blue
Labeler steriscience specialties private limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

methylene blue 50 mg/10mL

Manufacturer
Steriscience Specialties Private Limited

Identifiers & Regulatory

Product NDC 82449-003
Product ID 82449-003_4a8a9adf-f99b-6054-e063-6294a90ade62
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216955
Listing Expiration 2027-12-31
Marketing Start 2026-01-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82449003
Hyphenated Format 82449-003

Supplemental Identifiers

RxCUI
1788984 2731634
UPC
0382449002013
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 ANDA216955 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/10mL
source: ndc
Packaging
  • 5 SYRINGE in 1 CARTON (82449-003-06) / 10 mL in 1 SYRINGE
source: ndc

Packages (1)

82449-003-06 5 SYRINGE in 1 CARTON (82449-003-06) / 10 mL in 1 SYRINGE

Ingredients (1)

methylene blue (50 mg/10mL)

Linked Drug Pages (1)

Methylene blue ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4a8a9adf-f99b-6054-e063-6294a90ade62", "openfda": {"upc": ["0382449002013"], "unii": ["T42P99266K"], "rxcui": ["1788984", "2731634"], "spl_set_id": ["eb87d31c-3a8e-4089-9693-20bc17279650"], "manufacturer_name": ["Steriscience Specialties Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 SYRINGE in 1 CARTON (82449-003-06)  / 10 mL in 1 SYRINGE", "package_ndc": "82449-003-06", "marketing_start_date": "20260107"}], "brand_name": "Methylene blue", "product_id": "82449-003_4a8a9adf-f99b-6054-e063-6294a90ade62", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Oxidation-Reduction Activity [MoA]", "Oxidation-Reduction Agent [EPC]"], "product_ndc": "82449-003", "generic_name": "Methylene Blue", "labeler_name": "Steriscience Specialties Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylene blue", "active_ingredients": [{"name": "METHYLENE BLUE", "strength": "50 mg/10mL"}], "application_number": "ANDA216955", "marketing_category": "ANDA", "marketing_start_date": "20260107", "listing_expiration_date": "20271231"}