methylene blue

Generic: methylene blue

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

Drug Facts

Product Profile

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

methylene blue 5 mg/mL

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1837
Product ID 70710-1837_3fa12a10-2619-4a74-b2c5-6ad0cf17b0ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215636
Listing Expiration 2026-12-31
Marketing Start 2023-12-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101837
Hyphenated Format 70710-1837

Supplemental Identifiers

RxCUI
1788984 2199323
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 ANDA215636 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 5 VIAL in 1 CARTON (70710-1837-5) / 2 mL in 1 VIAL (70710-1837-1)
source: ndc

Packages (1)

70710-1837-5 5 VIAL in 1 CARTON (70710-1837-5) / 2 mL in 1 VIAL (70710-1837-1)

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": "3fa12a10-2619-4a74-b2c5-6ad0cf17b0ff", "openfda": {"unii": ["T42P99266K"], "rxcui": ["1788984", "2199323"], "spl_set_id": ["8c56fbad-a449-4ed4-a55f-1694e4e8e26a"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL in 1 CARTON (70710-1837-5)  / 2 mL in 1 VIAL (70710-1837-1)", "package_ndc": "70710-1837-5", "marketing_start_date": "20231205"}], "brand_name": "Methylene blue", "product_id": "70710-1837_3fa12a10-2619-4a74-b2c5-6ad0cf17b0ff", "dosage_form": "INJECTION", "pharm_class": ["Oxidation-Reduction Activity [MoA]", "Oxidation-Reduction Agent [EPC]"], "product_ndc": "70710-1837", "generic_name": "Methylene blue", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methylene blue", "active_ingredients": [{"name": "METHYLENE BLUE", "strength": "5 mg/mL"}], "application_number": "ANDA215636", "marketing_category": "ANDA", "marketing_start_date": "20231205", "listing_expiration_date": "20261231"}