trisenox

Generic: arsenic trioxide

Labeler: cephalon, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name trisenox
Generic Name arsenic trioxide
Labeler cephalon, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

arsenic trioxide 2 mg/mL

Manufacturer
Cephalon, LLC

Identifiers & Regulatory

Product NDC 63459-601
Product ID 63459-601_438426ea-1729-4b61-ad21-b979924204fe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021248
Listing Expiration 2026-12-31
Marketing Start 2017-12-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63459601
Hyphenated Format 63459-601

Supplemental Identifiers

RxCUI
1992545 1992547
UPC
0363459601069
UNII
S7V92P67HO

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 trisenox (source: ndc)
Generic Name arsenic trioxide (source: ndc)
Application Number NDA021248 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (63459-601-06) / 6 mL in 1 VIAL, SINGLE-DOSE (63459-601-11)
source: ndc

Packages (1)

Ingredients (1)

arsenic trioxide (2 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "438426ea-1729-4b61-ad21-b979924204fe", "openfda": {"upc": ["0363459601069"], "unii": ["S7V92P67HO"], "rxcui": ["1992545", "1992547"], "spl_set_id": ["101fc347-d0ad-4aee-8b06-9feb187fd741"], "manufacturer_name": ["Cephalon, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (63459-601-06)  / 6 mL in 1 VIAL, SINGLE-DOSE (63459-601-11)", "package_ndc": "63459-601-06", "marketing_start_date": "20171222"}], "brand_name": "Trisenox", "product_id": "63459-601_438426ea-1729-4b61-ad21-b979924204fe", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "63459-601", "generic_name": "Arsenic Trioxide", "labeler_name": "Cephalon, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trisenox", "active_ingredients": [{"name": "ARSENIC TRIOXIDE", "strength": "2 mg/mL"}], "application_number": "NDA021248", "marketing_category": "NDA", "marketing_start_date": "20171222", "listing_expiration_date": "20261231"}