provayblue

Generic: methylene blue

Labeler: american regent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name provayblue
Generic Name methylene blue
Labeler american regent, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

methylene blue 5 mg/mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-0371
Product ID 0517-0371_420bd985-ac55-44b9-b8a0-a5098220575b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204630
Listing Expiration 2026-12-31
Marketing Start 2020-04-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05170371
Hyphenated Format 0517-0371

Supplemental Identifiers

RxCUI
1788984 1788989 2199323 2199324
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 provayblue (source: ndc)
Generic Name methylene blue (source: ndc)
Application Number NDA204630 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-0371-05) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-0371-01)
source: ndc

Packages (1)

0517-0371-05 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-0371-05) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-0371-01)

Ingredients (1)

methylene blue (5 mg/mL)

Linked Drug Pages (1)

PROVAYBLUE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "420bd985-ac55-44b9-b8a0-a5098220575b", "openfda": {"unii": ["T42P99266K"], "rxcui": ["1788984", "1788989", "2199323", "2199324"], "spl_set_id": ["4f6848e5-35ed-4046-b13c-3032b5ba3232"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (0517-0371-05)  / 2 mL in 1 VIAL, SINGLE-DOSE (0517-0371-01)", "package_ndc": "0517-0371-05", "marketing_start_date": "20211231"}], "brand_name": "PROVAYBLUE", "product_id": "0517-0371_420bd985-ac55-44b9-b8a0-a5098220575b", "dosage_form": "INJECTION", "pharm_class": ["Oxidation-Reduction Activity [MoA]", "Oxidation-Reduction Agent [EPC]"], "product_ndc": "0517-0371", "generic_name": "methylene blue", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROVAYBLUE", "active_ingredients": [{"name": "METHYLENE BLUE", "strength": "5 mg/mL"}], "application_number": "NDA204630", "marketing_category": "NDA", "marketing_start_date": "20200408", "listing_expiration_date": "20261231"}