isosulfan blue

Generic: isosulfan blue

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

Drug Facts

Product Profile

Brand Name isosulfan blue
Generic Name isosulfan blue
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

isosulfan blue 10 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-805
Product ID 71288-805_1c9d3281-9ee0-4e8c-9d36-7736ada64138
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213130
Listing Expiration 2026-12-31
Marketing Start 2021-11-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288805
Hyphenated Format 71288-805

Supplemental Identifiers

UNII
39N9K8S2A4

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 isosulfan blue (source: ndc)
Generic Name isosulfan blue (source: ndc)
Application Number ANDA213130 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 6 VIAL, SINGLE-DOSE in 1 CARTON (71288-805-06) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-805-05)
source: ndc

Packages (1)

71288-805-06 6 VIAL, SINGLE-DOSE in 1 CARTON (71288-805-06) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-805-05)

Ingredients (1)

isosulfan blue (10 mg/mL)

Linked Drug Pages (1)

Isosulfan Blue ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "1c9d3281-9ee0-4e8c-9d36-7736ada64138", "openfda": {"unii": ["39N9K8S2A4"], "spl_set_id": ["d36ae5af-6351-497a-9151-82bcb2c62fa0"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 VIAL, SINGLE-DOSE in 1 CARTON (71288-805-06)  / 5 mL in 1 VIAL, SINGLE-DOSE (71288-805-05)", "package_ndc": "71288-805-06", "marketing_start_date": "20211103"}], "brand_name": "Isosulfan Blue", "product_id": "71288-805_1c9d3281-9ee0-4e8c-9d36-7736ada64138", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "71288-805", "generic_name": "Isosulfan Blue", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Isosulfan Blue", "active_ingredients": [{"name": "ISOSULFAN BLUE", "strength": "10 mg/mL"}], "application_number": "ANDA213130", "marketing_category": "ANDA", "marketing_start_date": "20211103", "listing_expiration_date": "20261231"}