methylene blue

Generic: methylene blue

Labeler: bpi labs llc
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name methylene blue
Generic Name methylene blue
Labeler bpi labs llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

methylene blue 10 mg/mL

Manufacturer
BPI LABS LLC

Identifiers & Regulatory

Product NDC 54288-159
Product ID 54288-159_e36054e3-076c-46d7-82f1-33b3d9481376
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2023-05-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54288159
Hyphenated Format 54288-159

Supplemental Identifiers

RxCUI
2637038
UPC
0354288159050 0354288159012
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)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 5 SYRINGE in 1 PACKAGE (54288-159-05) / 2 mL in 1 SYRINGE (54288-159-01)
source: ndc

Packages (1)

54288-159-05 5 SYRINGE in 1 PACKAGE (54288-159-05) / 2 mL in 1 SYRINGE (54288-159-01)

Ingredients (1)

methylene blue (10 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": "e36054e3-076c-46d7-82f1-33b3d9481376", "openfda": {"upc": ["0354288159050", "0354288159012"], "unii": ["T42P99266K"], "rxcui": ["2637038"], "spl_set_id": ["fbdd583d-45ba-4d42-8c80-9a13b71980b6"], "manufacturer_name": ["BPI LABS LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 SYRINGE in 1 PACKAGE (54288-159-05)  / 2 mL in 1 SYRINGE (54288-159-01)", "package_ndc": "54288-159-05", "marketing_start_date": "20230515"}], "brand_name": "Methylene Blue", "product_id": "54288-159_e36054e3-076c-46d7-82f1-33b3d9481376", "dosage_form": "INJECTION", "pharm_class": ["Oxidation-Reduction Activity [MoA]", "Oxidation-Reduction Agent [EPC]"], "product_ndc": "54288-159", "generic_name": "Methylene Blue", "labeler_name": "BPI LABS LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylene Blue", "active_ingredients": [{"name": "METHYLENE BLUE", "strength": "10 mg/mL"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20230515", "listing_expiration_date": "20261231"}