methylene blue

Generic: methylene blue

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

Drug Facts

Product Profile

Brand Name methylene blue
Generic Name methylene blue
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

methylene blue 5 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9094
Product ID 0143-9094_fd057210-bc2c-44d5-bf5d-b1f0a408a946
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216959
Listing Expiration 2027-12-31
Marketing Start 2025-06-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439094
Hyphenated Format 0143-9094

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 ANDA216959 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-DOSE in 1 CARTON (0143-9094-05) / 10 mL in 1 VIAL, SINGLE-DOSE (0143-9094-01)
source: ndc

Packages (1)

0143-9094-05 5 VIAL, SINGLE-DOSE in 1 CARTON (0143-9094-05) / 10 mL in 1 VIAL, SINGLE-DOSE (0143-9094-01)

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": "fd057210-bc2c-44d5-bf5d-b1f0a408a946", "openfda": {"unii": ["T42P99266K"], "rxcui": ["1788984"], "spl_set_id": ["4f222ee5-df03-46d5-a060-c63565b7186f"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 CARTON (0143-9094-05)  / 10 mL in 1 VIAL, SINGLE-DOSE (0143-9094-01)", "package_ndc": "0143-9094-05", "marketing_start_date": "20250605"}], "brand_name": "Methylene blue", "product_id": "0143-9094_fd057210-bc2c-44d5-bf5d-b1f0a408a946", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Oxidation-Reduction Activity [MoA]", "Oxidation-Reduction Agent [EPC]"], "product_ndc": "0143-9094", "generic_name": "Methylene Blue", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylene blue", "active_ingredients": [{"name": "METHYLENE BLUE", "strength": "5 mg/mL"}], "application_number": "ANDA216959", "marketing_category": "ANDA", "marketing_start_date": "20250605", "listing_expiration_date": "20271231"}