methylene blue

Generic: methylene blue

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methylene blue
Generic Name methylene blue
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

methylene blue 5 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-811
Product ID 71288-811_65ff33db-d8c2-4591-8988-78e08b2298b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217380
Listing Expiration 2026-12-31
Marketing Start 2025-01-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288811
Hyphenated Format 71288-811

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 ANDA217380 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (71288-811-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-811-10)
source: ndc

Packages (1)

71288-811-11 5 VIAL, SINGLE-DOSE in 1 CARTON (71288-811-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-811-10)

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": "65ff33db-d8c2-4591-8988-78e08b2298b6", "openfda": {"unii": ["T42P99266K"], "rxcui": ["1788984"], "spl_set_id": ["2566ce72-9d19-42e5-80f9-8fc4612b1eff"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (71288-811-11)  / 10 mL in 1 VIAL, SINGLE-DOSE (71288-811-10)", "package_ndc": "71288-811-11", "marketing_start_date": "20250123"}], "brand_name": "Methylene Blue", "product_id": "71288-811_65ff33db-d8c2-4591-8988-78e08b2298b6", "dosage_form": "INJECTION", "pharm_class": ["Oxidation-Reduction Activity [MoA]", "Oxidation-Reduction Agent [EPC]"], "product_ndc": "71288-811", "generic_name": "Methylene Blue", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylene Blue", "active_ingredients": [{"name": "METHYLENE BLUE", "strength": "5 mg/mL"}], "application_number": "ANDA217380", "marketing_category": "ANDA", "marketing_start_date": "20250123", "listing_expiration_date": "20261231"}